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PloS One 2019Whether all degrees of periventricular leukomalacia (PVL) and peri-intraventricular haemorrhage (PIVH) have a negative impact on neurodevelopment. (Meta-Analysis)
Meta-Analysis
CONTEXT
Whether all degrees of periventricular leukomalacia (PVL) and peri-intraventricular haemorrhage (PIVH) have a negative impact on neurodevelopment.
OBJECTIVE
To determine the impact of PVL and PIVH in the incidence of cerebral palsy, sensorineural impairment and development scores in preterm neonates. Registered in PROSPERO (CRD42017073113).
DATA SOURCES
PubMed, Embase, SciELO, LILACS, and Cochrane databases.
STUDY SELECTION
Prospective cohort studies evaluating neurodevelopment in children born preterm which performed brain imaging in the neonatal period.
DATA EXTRACTION
Two independent researchers extracted data using a predesigned data extraction sheet.
STATISTICAL METHODS
A random-effects model was used, with Mantel-Haenszel approach and a Sidik-Jonkman method for the estimation of variances, combined with Hartung-Knapp-Sidik-Jonkman correction. Heterogeneity was assessed through the I2 statistic and sensitivity analysis were performed when possible. No funnel plots were generated but publication bias was discussed as a possible limitation.
RESULTS
Our analysis concluded premature children with any degree of PIVH are at increased risk for cerebral palsy (CP) when compared to children with no PIVH (3.4, 95% CI 1.60-7.22; 9 studies), a finding that persisted on subgroup analysis for studies with mean birth weight of less than 1000 grams. Similarly, PVL was associated with CP, both in its cystic (19.12, 95% CI 4.57-79.90; 2 studies) and non-cystic form (9.27, 95% CI 5.93-14.50; 2 studies). We also found children with cystic PVL may be at risk for visual and hearing impairment compared to normal children, but evidence is weak.
LIMITATIONS
Major limitations were the lack of data for PVL in general, especially for the outcome of neurodevelopment, the high heterogeneity among methods used to assess neurodevelopment and the small number of studies, which led to meta-analysis with high heterogeneity and wide confidence intervals.
CONCLUSIONS
There was no evidence supporting the hypothesis that PIVH causes impairment in neuropsychomotor development in our meta-analysis, but review of newer studies show an increased risk for lower intelligence scores in children with severe lesions, both PIVH and PVL. There is evidence to support the hypothesis that children with any degree of PIVH, especially those born below 1000 grams and those with severe haemorrhage, are at increased risk of developing CP, as well as children with PVL, both cystic and non-cystic.
Topics: Cerebral Hemorrhage; Hearing Loss; Humans; Infant, Newborn; Infant, Premature; Leukomalacia, Periventricular; Nervous System; Treatment Outcome; Vision Disorders
PubMed: 31600248
DOI: 10.1371/journal.pone.0223427 -
Developmental Medicine and Child... Mar 2016The aim of this systematic review was to study motor and cognitive outcome in infants with severe early brain lesions and to evaluate effects of side of the lesion, sex,... (Review)
Review
The aim of this systematic review was to study motor and cognitive outcome in infants with severe early brain lesions and to evaluate effects of side of the lesion, sex, and social economic status on outcome. A literature search was performed using the databases Pubmed and Embase. Included studies involved infants with either cystic periventricular leukomalacia (cPVL), preterm, or term stroke (i.e. parenchymal lesion of the brain). Outcome was expressed as cerebral palsy (CP) and intellectual disability (mental retardation). Median prevalence rates of CP after cPVL, preterm, and term stroke were 86%, 71%, and 29% respectively; of intellectual disability 50%, 27%, and 33%. Most infants with cPVL developed bilateral CP, those with term stroke unilateral CP, whereas after preterm stroke bilateral and unilateral CP occurred equally often. Information on the effects of sex and social economic status on outcome after specific brain lesions was very limited. Our findings show that the risk for CP is high after cPVL, moderate after preterm stroke, and lowest after term stroke. The risk for intellectual disability after an early brain lesion is lower than that for CP. Predicting outcome at individual level remains difficult; new imaging techniques may improve predicting developmental trajectories.
Topics: Cerebral Palsy; Humans; Infant; Infant, Premature, Diseases; Intellectual Disability; Leukomalacia, Periventricular; Stroke
PubMed: 27027607
DOI: 10.1111/dmcn.13047 -
Ultrasound in Medicine & Biology Jul 2021Cranial ultrasound examinations are routinely performed in very preterm neonates. There is no widespread agreement on the optimal timing of these examinations. This...
Cranial ultrasound examinations are routinely performed in very preterm neonates. There is no widespread agreement on the optimal timing of these examinations. This review examines screening protocols and recommendations available for the timing of cranial ultrasound examinations in preterm neonates born before 32 wk of gestation. A systematic search was performed to find published screening protocols, and 18 articles were included in the final review. The protocols varied in their recommendations on timing, although at least one examination in the first week of life was universally recommended. The recommended timing for a "late" or final ultrasound examination was variable, and included at 6 wks of postnatal age, term-equivalent age or hospital discharge. There was no agreement as to whether weekly or fortnightly sequential ultrasound imaging should be performed after the first week of life. Further studies are required to establish an optimal protocol for these very preterm neonates to improve detection and monitoring of brain injuries.
Topics: Brain Diseases; Clinical Protocols; Echoencephalography; Humans; Infant, Newborn; Infant, Premature; Neonatal Screening
PubMed: 33895036
DOI: 10.1016/j.ultrasmedbio.2021.03.006 -
The Cochrane Database of Systematic... Oct 2017Effective synchronisation of infant respiratory effort with mechanical ventilation may allow adequate gas exchange to occur at lower peak airway pressures, potentially... (Review)
Review
BACKGROUND
Effective synchronisation of infant respiratory effort with mechanical ventilation may allow adequate gas exchange to occur at lower peak airway pressures, potentially reducing barotrauma and volutrauma and development of air leaks and bronchopulmonary dysplasia. During neurally adjusted ventilatory assist ventilation (NAVA), respiratory support is initiated upon detection of an electrical signal from the diaphragm muscle, and pressure is provided in proportion to and synchronous with electrical activity of the diaphragm (EADi). Compared to other modes of triggered ventilation, this may provide advantages in improving synchrony.
OBJECTIVES
Primary• To determine whether NAVA, when used as a primary or rescue mode of ventilation, results in reduced rates of bronchopulmonary dysplasia (BPD) or death among term and preterm newborn infants compared to other forms of triggered ventilation• To assess the safety of NAVA by determining whether it leads to greater risk of intraventricular haemorrhage (IVH), periventricular leukomalacia, or air leaks when compared to other forms of triggered ventilation Secondary• To determine whether benefits of NAVA differ by gestational age (term or preterm)• To determine whether outcomes of cross-over trials performed during the first two weeks of life include peak pressure requirements, episodes of hypocarbia or hypercarbia, oxygenation index, and the work of breathing SEARCH METHODS: We performed searches of the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cohrane Library; MEDLINE via Ovid SP (January 1966 to March 2017); Embase via Ovid SP (January 1980 to March 2017); the Cumulative Index to Nursing and Allied Health Literature (CINAHL) via EBSCO host (1982 to March 2017); and the Web of Science (1985 to 2017). We searched abstracts from annual meetings of the Pediatric Academic Societies (PAS) (2000 to 2016); meetings of the European Society of Pediatric Research (published in Pediatric Research); and meetings of the Perinatal Society of Australia and New Zealand (PSANZ) (2005 to 2016). We also searched clinical trials databases to March 2017.
SELECTION CRITERIA
We included randomised and quasi-randomised clinical trials including cross-over trials comparing NAVA with other modes of triggered ventilation (assist control ventilation (ACV),synchronous intermittent mandatory ventilation plus pressure support (SIMV ± PS), pressure support ventilation (PSV), or proportional assist ventilation (PAV)) used in neonates.
DATA COLLECTION AND ANALYSIS
Primary outcomes of interest from randomised controlled trials were all-cause mortality, bronchopulmonary dysplasia (BPD; defined as oxygen requirement at 28 days), and a combined outcome of all-cause mortality or BPD. Secondary outcomes were duration of mechanical ventilation, incidence of air leak, incidence of IVH or periventricular leukomalacia, and survival with an oxygen requirement at 36 weeks' postmenstrual age.Outcomes of interest from cross-over trials were maximum fraction of inspired oxygen, mean peak inspiratory pressure, episodes of hypocarbia, and episodes of hypercarbia measured across the time period of each arm of the cross-over. We planned to assess work of breathing; oxygenation index, and thoraco-abdominal asynchrony at the end of the time period of each arm of the cross-over study.
MAIN RESULTS
We included one randomised controlled study comparing NAVA versus patient-triggered time-cycled pressure-limited ventilation. This study found no significant difference in duration of mechanical ventilation, nor in rates of BPD, pneumothorax, or IVH.
AUTHORS' CONCLUSIONS
Risks and benefits of NAVA compared to other forms of ventilation for neonates are uncertain. Well-designed trials are required to evaluate this new form of triggered ventilation.
Topics: Bronchopulmonary Dysplasia; Cerebral Intraventricular Hemorrhage; Humans; Infant, Newborn; Interactive Ventilatory Support; Leukomalacia, Periventricular; Respiratory Mechanics
PubMed: 29077984
DOI: 10.1002/14651858.CD012251.pub2 -
Frontiers in Pediatrics 2022To evaluate the efficacy and safety of oropharyngeal administration of colostrum (OAC) in preterm infants.
OBJECTIVE
To evaluate the efficacy and safety of oropharyngeal administration of colostrum (OAC) in preterm infants.
METHODS
We searched Embase, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the website of the clinical trials, search time was from the establishment of the databases or websites up to 1 February 2022. Preterm infants with gestational age (GA) ≤ 32 weeks or birth weight (BW) ≤ 1500 g were taken as the participants, collect randomized controlled trials (RCTs) of comparing OAC and placebo or no intervention in preterm infants. Two researchers independently screened the literature, extracted the data, and evaluated the quality of the literature, and we adopted Review Manager 5.3 software for meta-analysis.
RESULTS
In total, 11 RCTs ( = 1,173) were included in the review. A meta-analysis showed significant difference in the incidence of necrotizing enterocolitis [NEC; = 0.009, relative ratio (RR) = 0.51, 95% confidence interval (CI) = 0.31-0.84], late-onset sepsis (LOS; = 0.02, RR = 0.75, 95% CI = 0.59-0.95), ventilator-associated pneumonia (VAP; = 0.03, RR = 0.48, 95% CI = 0.24-0.95), the time to reach full enteral feeds ( < 0.00001, mean difference (MD) = -3.40, 95% CI = -3.87 to -2.92), duration of hospital stay ( < 0.00001, MD = -10.00, 95% CI = -11.36 to -8.64), and the rate of weight gain (kg.d; < 0.00001, MD = 2.63, 95% CI = 2.10-3.16) between the colostrum group and control group. Meanwhile, researchers found no significant difference between the colostrum group and control group in the incidence of bronchopulmonary dysplasia (BPD; = 0.17, RR = 0.83, 95% CI = 0.64-1.08), intraventricular hemorrhage (IVH; grade ≥3; = 0.05, RR = 0.44, 95% CI = 0.19-1.01), periventricular leukomalacia (PVL; = 0.67, RR = 0.70, 95% CI = 0.14-3.49), retinopathy of prematurity (ROP; = 0.29, RR = 1.25, 95% CI = 0.82-1.89), and patent ductus arteriosus (PDA; = 0.17, RR = 1.22, 95% CI = 0.92-1.62).
CONCLUSION
Oropharyngeal administration of colostrum can reduce the incidence of NEC, LOS, and VAP in preterm infants, shortening the time to reach full enteral feeds, and duration of hospital stay, and increasing the rate of weight gain (kg.d). Therefore, OAC can be used as part of routine care for preterm infants.
PubMed: 35832583
DOI: 10.3389/fped.2022.895375 -
Brain Sciences Dec 2022To perform a systematic review and meta-analysis of existing literature to evaluate the incidence of cranial ultrasound abnormalities (CUAs) amongst moderate to late... (Review)
Review
AIM
To perform a systematic review and meta-analysis of existing literature to evaluate the incidence of cranial ultrasound abnormalities (CUAs) amongst moderate to late preterm (MLPT) and term infants, affected by fetal growth restriction (FGR) or those classified as small for gestational age (SGA).
METHODS
A systematic review methodology was performed, and Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) statement was utilised. Descriptive and observational studies reporting cranial ultrasound outcomes on FGR/SGA MLPT and term infants were included. Primary outcomes reported was incidence of CUAs in MLPT and term infants affected by FGR or SGA, with secondary outcomes including brain structure development and growth, and cerebral artery Dopplers. A random-effects model meta-analysis was performed. Risk of Bias was assessed using the Newcastle-Ottawa scale for case-control and cohort studies, and Joanna Briggs Institute Critical Appraisal Checklist for studies reporting prevalence data. GRADE was used to assess for certainty of evidence.
RESULTS
Out of a total of 2085 studies identified through the search, seventeen were deemed to be relevant and included. Nine studies assessed CUAs in MLPT FGR/SGA infants, seven studies assessed CUAs in late preterm and term FGR/SGA infants, and one study assessed CUAs in both MLPT and term FGR/SGA infants. The incidence of CUAs in MLPT, and late preterm to term FGR/SGA infants ranged from 0.4 to 33% and 0 to 70%, respectively. A meta-analysis of 7 studies involving 168,136 infants showed an increased risk of any CUA in FGR infants compared to appropriate for gestational age (AGA) infants (RR 1.96, [95% CI 1.26-3.04], = 68%). The certainty of evidence was very low due to non-randomised studies, methodological limitations, and heterogeneity. Another meta-analysis looking at 4 studies with 167,060 infants showed an increased risk of intraventricular haemorrhage in FGR/SGA infants compared to AGA infants (RR 2.40, [95% CI 2.03-2.84], = 0%). This was also of low certainty.
CONCLUSIONS
The incidence of CUAs in MLPT and term growth-restricted infants varied widely between studies. Findings from the meta-analyses suggest the risk of CUAs and IVH may indeed be increased in these FGR/SGA infants when compared with infants not affected by FGR, however the evidence is of low to very low certainty. Further specific cohort studies are needed to fully evaluate the benefits and prognostic value of cranial ultrasonography to ascertain the need for, and timing of a cranial ultrasound screening protocol in this infant population, along with follow-up studies to ascertain the significance of CUAs identified.
PubMed: 36552172
DOI: 10.3390/brainsci12121713 -
Frontiers in Neurology 2016Cerebral palsy (CP) is a complex multifactorial disorder, affecting approximately 2.5-3/1000 live term births, and up to 22/1000 prematurely born babies. CP results from... (Review)
Review
Cerebral palsy (CP) is a complex multifactorial disorder, affecting approximately 2.5-3/1000 live term births, and up to 22/1000 prematurely born babies. CP results from injury to the developing brain incurred before, during, or after birth. The most common form of this condition, spastic CP, is primarily associated with injury to the cerebral cortex and subcortical white matter as well as the deep gray matter. The major etiological factors of spastic CP are hypoxia/ischemia (HI), occurring during the last third of pregnancy and around birth age. In addition, inflammation has been found to be an important factor contributing to brain injury, especially in term infants. Other factors, including genetics, are gaining importance. The classic Rice-Vannucci HI model (in which 7-day-old rat pups undergo unilateral ligation of the common carotid artery followed by exposure to 8% oxygen hypoxic air) is a model of neonatal stroke that has greatly contributed to CP research. In this model, brain damage resembles that observed in severe CP cases. This model, and its numerous adaptations, allows one to finely tune the injury parameters to mimic, and therefore study, many of the pathophysiological processes and conditions observed in human patients. Investigators can recreate the HI and inflammation, which cause brain damage and subsequent motor and cognitive deficits. This model further enables the examination of potential approaches to achieve neural repair and regeneration. In the present review, we compare and discuss the advantages, limitations, and the translational value for CP research of HI models of perinatal brain injury.
PubMed: 27199883
DOI: 10.3389/fneur.2016.00057 -
The Cochrane Database of Systematic... Jan 2017Proper sedation for neonates undergoing uncomfortable procedures may reduce stress and avoid complications. Midazolam is a short-acting benzodiazepine that is used... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Proper sedation for neonates undergoing uncomfortable procedures may reduce stress and avoid complications. Midazolam is a short-acting benzodiazepine that is used increasingly in neonatal intensive care units (NICUs). However, its effectiveness as a sedative in neonates has not been systematically evaluated.
OBJECTIVES
Primary objeciveTo assess the effectiveness of intravenous midazolam infusion for sedation, as evaluated by behavioural and/or physiological measurements of sedation levels, in critically ill neonates in the NICU. Secondary objectivesTo assess effects of intravenous midazolam infusion for sedation on complications including the following.1. Incidence of intraventricular haemorrhage (IVH)/periventricular leukomalacia (PVL).2. Mortality.3. Occurrence of adverse effects associated with the use of midazolam (hypotension, neurological abnormalities).4. Days of ventilation.5. Days of supplemental oxygen.6. Incidence of pneumothorax.7. Length of NICU stay (days).8. Long-term neurodevelopmental outcomes.
SELECTION CRITERIA
We selected for review randomised and quasi-randomised controlled trials of intravenous midazolam infusion for sedation in infants aged 28 days or younger.
DATA COLLECTION AND ANALYSIS
We abstracted data regarding the primary outcome of level of sedation. We assessed secondary outcomes such as intraventricular haemorrhage, periventricular leukomalacia, death, length of NICU stay and adverse effects associated with midazolam. When appropriate, we performed meta-analyses using risk ratios (RRs) and risk differences (RDs), and if the RD was statistically significant, we calculated the number needed to treat for an additional beneficial outcome (NNTB) or an additional harmful outcome (NNTH), along with their 95% confidence intervals (95% CIs) for categorical variables, and weighted mean differences (WMDs) for continuous variables. We assessed heterogeneity by performing the I-squared (I2) test.
MAIN RESULTS
We included in the review three trials enrolling 148 neonates. We identified no new trials for this update. Using different sedation scales, each study showed a statistically significantly higher sedation level in the midazolam group compared with the placebo group. However, none of the sedation scales used have been validated in preterm infants; therefore, we could not ascertain the effectiveness of midazolam in this population. Duration of NICU stay was significantly longer in the midazolam group than in the placebo group (WMD 5.4 days, 95% CI 0.40 to 10.5; I2 = 0%; two studies, 89 infants). One study (43 infants) reported significantly lower Premature Infant Pain Profile (PIPP) scores during midazolam infusion than during dextrose (placebo) infusion (MD -3.80, 95% CI -5.93 to -1.67). Another study (46 infants) observed a higher incidence of adverse neurological events at 28 days' postnatal age (death, grade III or IV IVH or PVL) in the midazolam group compared with the morphine group (RR 7.64, 95% CI 1.02 to 57.21; RD 0.28, 95% CI 0.07 to 0.49; NNTH 4, 95% CI 2 to 14) (tests for heterogeneity not applicable). We considered these trials to be of moderate quality according to GRADE assessment based on the following outcomes: mortality during hospital stay, length of NICU stay, adequacy of analgesia according to PIPP scores and poor neurological outcomes by 28 days' postnatal age.
AUTHORS' CONCLUSIONS
Data are insufficient to promote the use of intravenous midazolam infusion as a sedative for neonates undergoing intensive care. This review raises concerns about the safety of midazolam in neonates. Further research on the effectiveness and safety of midazolam in neonates is needed.
Topics: Humans; Hypnotics and Sedatives; Infant, Newborn; Infant, Premature; Infusions, Intravenous; Intensive Care Units, Neonatal; Intensive Care, Neonatal; Length of Stay; Midazolam; Randomized Controlled Trials as Topic
PubMed: 28141899
DOI: 10.1002/14651858.CD002052.pub3 -
The Cochrane Database of Systematic... Feb 2015Lactoferrin, a normal component of human colostrum and milk, can enhance host defense and may be effective in the prevention of sepsis and necrotizing enterocolitis... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Lactoferrin, a normal component of human colostrum and milk, can enhance host defense and may be effective in the prevention of sepsis and necrotizing enterocolitis (NEC) in preterm neonates.
OBJECTIVES
Primary objective To assess the safety and effectiveness of oral lactoferrin in the prevention of sepsis and NEC in preterm neonates. Secondary objectives1. To determine the effects of oral lactoferrin used to prevent neonatal sepsis and/or NEC on duration of positive-pressure ventilation, development of chronic lung disease (CLD) or periventricular leukomalacia (PVL), length of hospital stay to discharge among survivors, and adverse neurological outcomes at two years of age or later.2. To determine the adverse effects of oral lactoferrin in the prophylaxis of neonatal sepsis and/or NEC.When data were available, we analyzed the following subgroups.1. Gestational age < 32 weeks and 32 to 36 weeks.2. Birth weight < 1000 g (extremely low birth weight (ELBW) infants) and birth weight < 1500 g (very low birth weight (VLBW) infants).3. Type of feeding: breast milk versus formula milk.
SEARCH METHODS
We used the search strategy of the Cochrane Neonatal Review Group (CNRG) and updated our search in July 2014. We searched the databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PREMEDLINE, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL), as well as trials registries and conference proceedings.
SELECTION CRITERIA
Randomized controlled trials (RCTs) evaluating oral lactoferrin at any dose or duration to prevent sepsis or NEC in preterm neonates.
DATA COLLECTION AND ANALYSIS
Review authors used standard methods of the CNRG.
MAIN RESULTS
Four RCTs are included in this review. Oral lactoferrin supplementation decreased late-onset sepsis (typical risk ratio (RR) 0.49, 95% confidence interval (CI) 0.32 to 0.73; typical risk difference (RD) -0.09, 95% CI -0.14 to -0.04; number needed to treat for an additional beneficial outcome (NNTB) 11, 95% CI 7 to 25; four trials, 678 participants, moderate-quality evidence), NEC stage II or greater (typical RR 0.30, 95% CI 0.12 to 0.76; typical RD -0.05, 95% CI -0.08 to -0.01; NNTB 20, 95% CI 12.5 to 100; two studies, 505 participants, low-quality evidence), and "all-cause mortality" (typical RR 0.30, 95% CI 0.12 to 0.75; typical RD -0.05, 95% CI -0.08 to -0.01; NNTB 20, 95% CI 12.5 to 100; two studies, 505 participants, low-quality evidence).Oral lactoferrin supplementation with a probiotic decreased late-onset sepsis (RR 0.27, 95% CI 0.12 to 0.60; RD -0.13, 95% CI -0.19 to -0.06; NNTB 8, 95% CI 5 to 17; one study, 321 participants, low-quality evidence) and NEC stage II or greater (RR 0.04, 95% CI 0.00 to 0.62; RD -0.05, 95% CI -0.08 to -0.03; NNTB 20, 95% CI 12.5 to 33.3; one study, 496 participants, low-quality evidence), but not "all-cause mortality."Oral lactoferrin with or without probiotics decreased fungal sepsis but not chronic lung disease or length of hospital stay (from one study, low-quality evidence). No adverse effects were reported. Long-term neurological outcomes or periventricular leukomalacia was not evaluated.
AUTHORS' CONCLUSIONS
Evidence of moderate to low quality suggests that oral lactoferrin prophylaxis with or without probiotics decreases late-onset sepsis and NEC stage II or greater in preterm infants without adverse effects. Completion of ongoing trials will provide evidence from more than 6000 preterm neonates and may enhance the quality of the evidence. Clarifications regarding optimum dosing regimens, type of lactoferrin (human or bovine), and long-term outcomes are still needed.
Topics: Administration, Oral; Enterocolitis, Necrotizing; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Lacticaseibacillus rhamnosus; Lactoferrin; Probiotics; Randomized Controlled Trials as Topic; Sepsis
PubMed: 25699678
DOI: 10.1002/14651858.CD007137.pub4 -
The Cochrane Database of Systematic... Jul 2016Preterm prelabour rupture of the membranes (PPROM) complicates approximately 2% of pregnancies and can be either spontaneous or iatrogenic in nature. Complications of... (Review)
Review
BACKGROUND
Preterm prelabour rupture of the membranes (PPROM) complicates approximately 2% of pregnancies and can be either spontaneous or iatrogenic in nature. Complications of PPROM include prematurity, chorioamnionitis, neonatal sepsis, limb position defects, respiratory distress syndrome, pulmonary hypoplasia chronic lung disease, periventricular leukomalacia and intraventricular haemorrhage.A number of different sealing techniques have been employed which aim to restore a physical barrier against infection and encourage the re-accumulation of amniotic fluid. Routine use of sealants is currently not recommended due to a lack of sufficient evidence to support the safety and effectiveness of such interventions.
OBJECTIVES
To assess the effects of sealing techniques following PPROM against each other, or versus standard care (including no sealant), on maternal and neonatal outcomes.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 May 2016) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials comparing different techniques for sealing preterm prelabour ruptured membranes. Cluster-randomised trials and trials using a cross-over design were not eligible for inclusion in this review. We planned to include abstracts when sufficient information was provided.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and assessed trial quality. Two review authors independently extracted data. Data were checked for accuracy.
MAIN RESULTS
We included two studies (involving 141 women - with data from 124 women). We considered both studies as being at high risk of bias. Meta-analysis was not possible because the included studies examined different interventions (both in comparison with standard care) and reported on few, but different, outcomes. One study compared cervical adapter (mechanical sealing), and the other study examined an immunological membrane sealant. Neither of the included studies reported on this review's primary outcome of interest - perinatal mortality. Similarly, data were not reported for the majority of this review's secondary infant and maternal outcomes. Cervical adapter (mechanical sealing) versus standard care (one study, data from 35 participants)No data were reported for this review's primary outcome - perinatal mortality. Data were reported for few of this review's infant or maternal secondary outcomes.There was no clear difference between the mechanical sealing group and the standard care control in relation to the incidence of neonatal sepsis (risk ratio (RR) 1.19, 95% confidence interval (CI) 0.28 to 5.09 (very low-quality evidence)) or chorioamnionitis (RR 1.19, 95% CI 0.28 to 5.09 (very low-quality evidence)). Oral immunological membrane sealant versus standard care (one study, data from 94 participants)No data were available for perinatal mortality (this review's primary outcome) or for the majority of this review's infant and maternal secondary outcomes. Compared to standard care, the immunological membrane sealant was associated with a reduction in preterm birth less than 37 weeks (RR 0.48, 95% CI 0.34 to 0.68 (very low-quality evidence)) and a reduction in neonatal death (RR 0.38, 95% CI 0.19 to 0.75 (very low-quality evidence)). However, there was no clear difference between groups in terms of neonatal sepsis (RR 0.64, 95% CI 0.28 to 1.46 (very low-quality evidence)) or respiratory distress syndrome (RR 0.64, 95% CI 0.28 to 1.46 (very low-quality evidence)).
AUTHORS' CONCLUSIONS
There is insufficient evidence to evaluate sealing procedures for PPROM. There were no data relating to this review's primary outcome (perinatal mortality) and the majority of our infant and maternal secondary outcomes were not reported in the two included studies.There was limited evidence to suggest that an immunological membrane sealant was associated with a reduction in preterm birth at less than 37 weeks and neonatal death, but these results should be interpreted with caution as this is based on one small study, with a high risk of bias, and the intervention has not been tested in other studies.Although midtrimester PPROM is not a rare occurrence, there are only a small amount of published data addressing the benefits and risks of sealing procedures. Most of these studies are retrospective and cohort based and could therefore not be included in our data-analysis.This review highlights the paucity of prospective randomised trials in this area. Current evidence provides limited information both on effectiveness and safety for the interventions described. Given the paucity of high-quality data, we recommend that future research efforts focus on the conduct of randomised trials assessing the effect of promising interventions that have been only evaluated to date in cohort studies (e.g. amniopatch). Future trials should address outcomes including perinatal mortality, preterm birth, neonatal death, respiratory distress syndrome, neonatal sepsis and developmental delay. They should also evaluate maternal outcomes including sepsis, mode of delivery, length of hospital stay and emotional well-being.
Topics: Equipment Design; Female; Fetal Membranes, Premature Rupture; Humans; Immunologic Factors; Negative-Pressure Wound Therapy; Obstetric Labor, Premature; Pregnancy; Randomized Controlled Trials as Topic
PubMed: 27384151
DOI: 10.1002/14651858.CD010218.pub2