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Journal de Gynecologie, Obstetrique Et... Dec 2013To describe early complications and management of the small for gestational age (SGA) neonate. (Review)
Review
OBJECTIVE
To describe early complications and management of the small for gestational age (SGA) neonate.
METHODS
This systematic evidence review is based on Pubmed search, Cochrane library and experts recommendations. Words included in the search mainly were: small for gestational age, intrauterine growth restriction, fetal growth restriction, very low birth weight infants, neonatal management, neonatal outcome, neonatal morbidity, neonatal mortality
RESULTS
Neonatal mortality relative risk among SGA infants is 2-4 times higher than adapted for gestational age (AGA) newborn infants, at any gestational age. SGA infants had an increased risk for perinatal asphyxia, hypothermia and hypoglycaemia during their first days of life. In the SGA preterm population, bronchopulmonary dysplasia, pulmonary hypertension and necrotising enterocolitis are significantly more frequent as compared with AGA population. Periventricular leukomalacia is not significantly different between SGA and AGA infants whereas intraventricular hemorrhage and retinopathy risks are discussed. Adaptive problems require paediatric contact before birth. Early management of the small for gestational age includes intervention to prevent hypothermia, the use of pressure controlled ventilator if needed, and close blood glucose monitoring.
CONCLUSIONS
SGA infants had excess neonatal mortality and morbidity in comparison with adapted ones for gestational age (AGA) infants, especially for preterm infants.
Topics: Female; Fetal Growth Retardation; Humans; Infant Mortality; Infant, Newborn; Infant, Newborn, Diseases; Infant, Small for Gestational Age; Pregnancy; Pregnancy Outcome; Treatment Outcome
PubMed: 24210715
DOI: 10.1016/j.jgyn.2013.09.020 -
Archives of Disease in Childhood. Fetal... Jul 2020To determine (1) the incidence of neurodevelopmental impairment (NDI) in necrotising enterocolitis (NEC), (2) the impact of NEC severity on NDI in these babies and (3)... (Meta-Analysis)
Meta-Analysis
AIM
To determine (1) the incidence of neurodevelopmental impairment (NDI) in necrotising enterocolitis (NEC), (2) the impact of NEC severity on NDI in these babies and (3) the cerebral lesions found in babies with NEC.
METHODS
Systematic review: three independent investigators searched for studies reporting infants with NDI and a history of NEC (PubMed, Medline, Cochrane Collaboration, Scopus). Meta-analysis: using RevMan V.5.3, we compared NDI incidence and type of cerebral lesions between NEC infants versus preterm infants and infants with medical vs surgical NEC.
RESULTS
Of 10 674 abstracts screened, 203 full-text articles were examined. In 31 studies (n=2403 infants with NEC), NDI incidence was 40% (IQR 28%-64%) and was higher in infants with surgically treated NEC (43%) compared with medically managed NEC (27%, p<0.00001). The most common NDI in NEC was cerebral palsy (18%). Cerebral lesions: intraventricular haemorrhage (IVH) was more common in NEC babies (26%) compared with preterm infants (18%; p<0.0001). There was no difference in IVH incidence between infants with surgical NEC (25%) and those treated medically (20%; p=0.4). The incidence of periventricular leukomalacia (PVL) was significantly increased in infants with NEC (11%) compared with preterm infants (5%; p<0.00001).
CONCLUSIONS
This study shows that a large proportion of NEC survivors has NDI. NEC babies are at higher risk of developing IVH and/or PVL than babies with prematurity alone. The degree of NDI seems to correlate to the severity of gut damage, with a worse status in infants with surgical NEC compared with those with medical NEC.
TRIAL REGISTRATION NUMBER
CRD42019120522.
Topics: Cerebellum; Enterocolitis, Necrotizing; Humans; Incidence; Infant, Newborn; Neurodevelopmental Disorders
PubMed: 31801792
DOI: 10.1136/archdischild-2019-317830 -
Archives of Disease in Childhood. Fetal... May 2021The association between maternal diabetes and outcomes of infants who are born preterm is unclear. (Meta-Analysis)
Meta-Analysis
CONTEXT
The association between maternal diabetes and outcomes of infants who are born preterm is unclear.
OBJECTIVE
To perform a systematic review and meta-analysis of clinical studies exploring the association between maternal diabetes and preterm infant outcomes.
METHODS
Medline, PubMed and Cumulative Index of Nursing and Allied Health Literature databases were searched without language restriction from 1 January 2000 until 19 August 2019. Studies examining preterm infants <37 weeks gestational age and reporting prespecified outcomes of this review based on maternal diabetes as primary exposure variable were included.
RESULTS
Of 7956 records identified through database searches, 9 studies were included in the study. No significant association was found between maternal diabetes and in-hospital mortality (adjusted RR (aRR) 0.90 (95% CI 0.73 to 1.11); 6 studies; participants=1 191 226; I=83%). Similarly, no significant association was found between maternal diabetes and bronchopulmonary dysplasia (aRR 1.00 (95% CI 0.92 to 1.07); 4 studies; participants=107 902; I=0%), intraventricular haemorrhage or cystic periventricular leukomalacia (aRR 0.91 (95% CI 0.80 to 1.03); 3 studies; participants=115 050; I=0%), necrotising enterocolitis (aRR 1.13 (95% CI 0.90 to 1.42); 5 studies; participants=142 579; I=56%) and retinopathy of prematurity (ROP) (aRR 1.17 (95% CI 0.85 to 1.61); 5 studies; participants=126 672; I=84). A sensitivity analysis where low risk of bias studies were included in the meta-analyses showed similar results; however, the heterogeneity was lower for in-hospital mortality and ROP.
CONCLUSION
Maternal diabetes was not associated with in-hospital mortality and severe neonatal morbidities in preterm infants. Future studies should explore the association between the severity of maternal diabetes with preterm infant outcomes.
Topics: Adult; Correlation of Data; Female; Hospital Mortality; Humans; Infant; Infant Mortality; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Pregnancy; Pregnancy in Diabetics; Severity of Illness Index
PubMed: 33172874
DOI: 10.1136/archdischild-2020-320054 -
The Cochrane Database of Systematic... 2003Inotropes are widely used in preterm infants to treat systemic hypotension. The most commonly used drugs are dopamine and dobutamine. These agents have different modes... (Review)
Review
BACKGROUND
Inotropes are widely used in preterm infants to treat systemic hypotension. The most commonly used drugs are dopamine and dobutamine. These agents have different modes of action which may result in different haemodynamic effects.
OBJECTIVES
To compare the effectiveness and safety of dopamine and dobutamine in the treatment of systemic hypotension in preterm infants.
SEARCH STRATEGY
Searches of electronic and other databases were performed including MEDLINE (1966-2002), EMBASE (1988-2002), Science Citation Index (1981-2002), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 2, 2003). Previous reviews were searched for references to relevant trials and leading authors in the field were contacted for information about other published and unpublished studies.
SELECTION CRITERIA
Randomised controlled trials where short and/or long term effects of treatment with dopamine and dobutamine for the treatment of systemic arterial hypotension were compared were selected for this review. Trials studying newborn infants born before 37 completed weeks gestation and less than 28 days of age were eligible for inclusion. Systemic arterial hypotension was not defined specifically, but accepted as defined in individual studies. Studies were not limited by birthweight, lower gestational age threshold or by route or duration of administration of inotropic agents. Study quality and eligibility were assessed independently by each reviewer.
DATA COLLECTION AND ANALYSIS
Data extraction was performed independently by each reviewer, with differences being resolved by discussion. The following outcomes were determined: mortality in the neonatal period, long term neurodevelopmental outcome, radiological evidence of severe neurological injury, short term haemodynamic changes and incidence of adverse effects. The effect of interventions was expressed either as Relative Risk (RR), Risk Difference (RD) or as Weighted Mean Difference (WMD) with their 95% Confidence Interval (CI).
MAIN RESULTS
Five trials met the pre-defined criteria for inclusion in this review. There was no evidence of a significant difference between dopamine and dobutamine in terms of neonatal mortality (RD 0.02 95% CI -0.12 to 0.16), incidence of periventricular leukomalacia (RD -0.08, 95% CI -0.19 to 0.04), or severe periventricular haemorrhage (RD -0.02, 95% CI -0.13 to 0.09). Dopamine was more successful than dobutamine in treating systemic hypotension, with fewer infants having treatment failure (RD -0.23, 95% CI -0.34 to -0.13; NNT = 4.4, 95% CI 2.9 to 7.7). Treatment with dobutamine was associated with a significantly greater increase in left ventricular output in the single study reporting that outcome. There was no evidence of a significant difference between the two agents with respect to the incidence of tachycardia (RD -0.06, 95% CI -0.25 to 0.14). None of the studies reported the incidence of adverse long term neurodevelopmental outcome.
REVIEWER'S CONCLUSIONS
Dopamine is more effective than dobutamine in the short term treatment of systemic hypotension in preterm infants. There was no evidence of an effect on the incidence of adverse neuroradiological sequelae (severe periventricular haemorrhage and/or periventricular leucomalacia), or on the incidence of tachycardia. However, in the absence of data confirming long term benefit and safety of dopamine compared to dobutamine, no firm recommendations can be made regarding the choice of drug to treat hypotension.
Topics: Cardiotonic Agents; Dobutamine; Dopamine; Humans; Hypotension; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Randomized Controlled Trials as Topic
PubMed: 12917901
DOI: 10.1002/14651858.CD001242 -
Developmental Medicine and Child... Jun 2016There is a large literature reporting risk factor analyses for poor neurodevelopment in children born very preterm (VPT: ≤32wks) or very low birthweight (VLBW:... (Review)
Review
AIM
There is a large literature reporting risk factor analyses for poor neurodevelopment in children born very preterm (VPT: ≤32wks) or very low birthweight (VLBW: ≤1250g), which to date has not been formally summarized. The aim of this paper was to identify prognostic factors for cerebral palsy (CP) and motor impairment in children born VPT/VLBW.
METHOD
A systematic review was conducted using Medline, Embase, and Pyscinfo databases to identify studies published between 1 January 1990 and 1 June 2014 reporting multivariable prediction models for poor neurodevelopment in VPT/VLBW children (registration number CRD42014006943). Twenty-eight studies for motor outcomes were identified.
RESULTS
There was strong evidence that intraventricular haemorrhage and periventricular leukomalacia, and some evidence that the use of postnatal steroids and non-use of antenatal steroids, were prognostic factors for CP. Male sex and gestational age were of limited use as prognostic factors for CP in cohorts restricted to ≤32 weeks gestation; however, in children older than 5 years with no major disability, there was evidence that male sex was a predictive factor for motor impairment.
INTERPRETATION
This review has identified factors which may be of prognostic value for CP and motor impairment in VPT/VLBW children and will help to form the basis of future prognostic research.
Topics: Cerebral Palsy; Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Male; Movement Disorders
PubMed: 26862030
DOI: 10.1111/dmcn.12972 -
The Cochrane Database of Systematic... 2003Although the overall incidence of neonatal sepsis has declined over the past decade, mortality remains high in the pre term infant. The high level of mortality and... (Review)
Review
BACKGROUND
Although the overall incidence of neonatal sepsis has declined over the past decade, mortality remains high in the pre term infant. The high level of mortality and morbidity from sepsis despite the use of potent anti-microbial agents, and the global emergence of antibiotic resistance, have led to the search for new modalities to boost new born host defences. Pentoxifylline, a xanthine derivative and a phosphodiesterase inhibitor, has been shown to possess a broad spectrum of activity modulating inflammation.
OBJECTIVES
The primary objective was to assess the effect on mortality and the safety of intravenous pentoxifylline as an adjunct to antibiotic therapy in neonates with suspected or confirmed sepsis.
SEARCH STRATEGY
The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2002), MEDLINE, EMBASE and CINAHL were searched in October 2002 and again in March 2003. Science Citation Index for articles referencing Lauterbach 1996 and Lauterbach 1999 was searched as well as proceedings of the Pediatric Academic Societies which were published in Pediatric Research from 1980. Doctoral dissertations and theses were searched from 1980. The reference lists of identified RCTs, and personal files were searched. No language restriction was applied.
SELECTION CRITERIA
Studies were included if they were randomised or quasi-randomised trials, assessing the efficacy of pentoxifylline compared to placebo or no intervention as an adjunct to antibiotic therapy of suspected or confirmed sepsis in newborn infants less than 28 days old. Eligible trials were required to report treatment effects on at least one of the following outcomes: all cause mortality during initial hospital stay, neurological development at two years of age or later, length of hospital stay, duration of ventilation via endotracheal intubation, chronic lung disease in survivors, periventricular leukomalacia, necrotising enterocolitis, or adverse events.
DATA COLLECTION AND ANALYSIS
Two reviewers independently abstracted information for the outcomes of interest. Any differences were resolved by mutual discussion. Typical Relative Risk (RR) and Risk Difference (RD) with 95% confidence intervals (CI) using fixed effects model are reported for dichotomous outcomes. NNT was calculated for outcomes for which there was a statistically significant reduction in RD.
MAIN RESULTS
Two RCTs enrolled a total of 140 preterm (< 36 weeks) neonates with suspected late onset (> 7 days) sepsis to evaluate the effect of pentoxifylline on neonatal outcomes. However, the two studies reported outcomes of only the 107 randomised patients with confirmed sepsis. The results showed a reduction in 'all cause mortality during hospital stay' following pentoxifylline treatment [typical RR 0.14 (95% CI 0.03, 0.76), RD -0.16 (95% CI -0.27, - 0.04), NNT 6 (95% CI 4, 25)]. No adverse effects due to pentoxifylline were observed in the two included trials. No other outcomes of interest were reported.
REVIEWER'S CONCLUSIONS
Current evidence suggests that the use of pentoxifylline as an adjunct to antibiotics in neonatal sepsis reduces mortality without any adverse effects. But the number of neonates studied is small and considerable methodological weaknesses exist in the included trials. Hence these results should be interpreted with caution. Researchers are encouraged to undertake large well-designed trials to confirm or refute the effectiveness of pentoxifylline to reduce mortality and adverse outcomes in neonates with suspected or confirmed neonatal sepsis. Researchers might also compare pentoxifylline with other adjuncts to antibiotics which modulate inflammation (e.g. intravenous immunoglobulins, haematopoetic colony stimulating factors among others) in reducing mortality and morbidity due to neonatal sepsis.
Topics: Anti-Bacterial Agents; Anti-Inflammatory Agents; Bacterial Infections; Chemotherapy, Adjuvant; Humans; Infant, Newborn; Infant, Premature; Pentoxifylline; Phosphodiesterase Inhibitors; Randomized Controlled Trials as Topic; Sepsis
PubMed: 14584009
DOI: 10.1002/14651858.CD004205 -
American Journal of Obstetrics and... Feb 2021The objective of this study was to provide a systematic review and meta-analysis to quantify prognosis and identify factors associated with variations in reported... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The objective of this study was to provide a systematic review and meta-analysis to quantify prognosis and identify factors associated with variations in reported mortality estimates among infants who were born at 22 weeks of gestation and provided proactive treatment (resuscitation and intensive care).
DATA SOURCES
PubMed, Scopus, and Web of Science databases, with no language restrictions, were searched for articles published from January 2000 to February 2020.
STUDY ELIGIBILITY CRITERIA
Reports on live-born infants who were delivered at 22 weeks of gestation and provided proactive care were included. The primary outcome was survival to hospital discharge; secondary outcomes included survival without major morbidity and survival without neurodevelopmental impairment. Because we expected differences across studies in the definitions for various morbidities, multiple definitions for composite outcomes of major morbidities were prespecified. Neurodevelopmental impairment was based on Bayley Scales of Infant Development II or III. Data extractions were performed independently, and outcomes agreed on a priori.
STUDY APPRAISAL AND SYNTHESIS METHODS
Methodological quality was assessed using the Quality in Prognostic Studies tool. An adapted version of the Grading of Recommendations Assessment, Development and Evaluation approach for prognostic studies was used to evaluate confidence in overall estimates. Outcomes were assessed as prevalence and 95% confidence intervals. Variabilities across studies attributable to heterogeneity were estimated with the I statistic; publication bias was assessed with the Luis Furuya-Kanamori index. Data were pooled using the inverse variance heterogeneity model.
RESULTS
Literature searches returned 21,952 articles, with 2034 considered in full; 31 studies of 2226 infants who were delivered at 22 weeks of gestation and provided proactive neonatal treatment were included. No articles were excluded for study design or risk of bias. The pooled prevalence of survival was 29.0% (95% confidence interval, 17.2-41.6; 31 studies, 2226 infants; I=79.4%; Luis Furuya-Kanamori index=0.04). Survival among infants born to mothers receiving antenatal corticosteroids was twice the survival of infants born to mothers not receiving antenatal corticosteroids (39.0% vs 19.5%; P<.01). The overall prevalence of survival without major morbidity, using a definition that includes any bronchopulmonary dysplasia, was 11.0% (95% confidence interval, 8.0-14.3; 10 studies, 374 infants; I=0%; Luis Furuya-Kanamori index=3.02). The overall rate of survival without moderate or severe impairment was 37.0% (95% confidence interval, 14.6-61.5; 5 studies, 39 infants; I=45%; Luis Furuya-Kanamori index=-0.15). Based on the year of publication, survival rates increased between 2000 and 2020 (slope of the regression line=0.09; standard error=0.03; P<.01). Studies were highly diverse with regard to interventions and outcomes reported.
CONCLUSION
The reported survival rates varied greatly among studies and were likely influenced by combining observational data from disparate sources, lack of individual patient-level data, and bias in the component studies from which the data were drawn. Therefore, pooled results should be interpreted with caution. To answer fundamental questions beyond the breadth of available data, multicenter, multidisciplinary collaborations, including alignment of important outcomes by stakeholders, are needed.
Topics: Adrenal Cortex Hormones; Bronchopulmonary Dysplasia; Cerebral Intraventricular Hemorrhage; Enterocolitis, Necrotizing; Fetal Viability; Gestational Age; Humans; Infant, Extremely Premature; Infant, Newborn; Intensive Care, Neonatal; Leukomalacia, Periventricular; Neurodevelopmental Disorders; Prenatal Care; Resuscitation; Retinopathy of Prematurity; Severity of Illness Index; Survival Rate
PubMed: 32745459
DOI: 10.1016/j.ajog.2020.07.051 -
The Cochrane Database of Systematic... Jun 2012Proper sedation for neonates undergoing uncomfortable procedures may reduce stress and avoid complications. Midazolam is a short-acting benzodiazepine that is... (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 increasingly used in neonatal intensive care units (NICU). However, its effectiveness as a sedative in neonates has not been systematically evaluated.
OBJECTIVES
To determine whether intravenous midazolam infusion is an effective sedative, as evaluated by behavioural or physiological measurements, or both, for critically ill neonates undergoing intensive care and to assess clinically significant short- and long-term adverse effects associated with its use.
SEARCH METHODS
We performed a literature search according to the Cochrane Neonatal Review Group search strategy. Randomised and quasi-randomised controlled trials of intravenous midazolam use in neonates were identified by searching the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2012), MEDLINE (1985 to 2012), EMBASE (1980 to 2012), CINAHL (1981 to 2012), reference lists of published studies, personal files, and abstracts published in The Pediatric Academic Societies Meeting Abstract Archives from 1990 to 2011.
SELECTION CRITERIA
Randomised and quasi-randomised controlled trials of intravenous midazolam infusion in infants aged 28 days or less for sedation were selected for review.
DATA COLLECTION AND ANALYSIS
Data regarding the primary outcome of level of sedation were abstracted. Secondary outcomes such as intraventricular haemorrhage (IVH), periventricular leukomalacia (PVL), death, length of NICU stay, and adverse effects associated with midazolam were assessed. When appropriate, meta-analyses were performed using risk ratio (RR), risk difference (RD), along with their 95% confidence intervals (95% CI) for categorical variables and weighted mean difference (WMD) for continuous variables.
MAIN RESULTS
Three trials were included in the review. Using different sedation scales, each study showed a statistically significantly higher sedation level in the midazolam group compared to the placebo group. However, since none of the sedation scales used have been validated in preterm infants, the effectiveness of midazolam in this population could not be ascertained. One study showed a statistically significant higher incidence of adverse neurological events (death, grade III or IV IVH, PVL), and meta-analysis of data from two studies showed a statistically significant longer duration of NICU stay in the midazolam group compared to the placebo group.
AUTHORS' CONCLUSIONS
There are insufficient data 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; Infusions, Intravenous; Intensive Care Units, Neonatal; Intensive Care, Neonatal; Midazolam; Randomized Controlled Trials as Topic
PubMed: 22696328
DOI: 10.1002/14651858.CD002052.pub2 -
Archives of Disease in Childhood. Fetal... Mar 2014To assess the effect of volume-targeted ventilation (VTV) compared with pressure-limited ventilation (PLV) in preterm infants. (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To assess the effect of volume-targeted ventilation (VTV) compared with pressure-limited ventilation (PLV) in preterm infants.
METHOD
We searched the Cochrane Library (Issue 3, 2013), PubMed (1966 to 5 March 2013), China National Knowledge Infrastructure (CNKI) and periodical databases (1979 to 5 March 2013). We selected randomised controlled trials (RCTs) and quasi-RCTs of VTV versus PLV as active interventions in preterm infants. We performed meta-analyses using the Cochrane statistical package RevMan 5.0.
RESULTS
Eighteen trials met our inclusion criteria. There was no evidence that VTV modes reduced the incidence of death (relative risk (RR) 0.73, 95% CI 0.51 to 1.05). The use of VTV modes resulted in a reduction in the incidence of bronchopulmonary dysplasia (BPD) (RR 0.61, 95% CI 0.46 to 0.82) and duration of mechanical ventilation (mean difference (MD) -2.0 days, 95% CI -3.14 to -0.86). VTV modes also resulted in reductions in intraventricular haemorrhage (IVH) (RR 0.65, 95% CI 0.42 to 0.99), grade 3/4 IVH (RR 0.55, 95% CI 0.39 to 0.79), periventricular leukomalacia (PVL) (RR 0.33, 95% CI 0.15 to 0.72), pneumothorax (RR 0.52, 95% CI 0.29 to 0.93), failure of primary mode of ventilation (RR 0.64, 95% CI 0.43 to 0.94), hypocarbia (RR 0.56, 95% CI 0.33 to 0.96), mean airway pressure (MD -0.54 cmH2O, 95% CI -1.05 to -0.02) and days of supplemental oxygen administration (MD -1.68 days, 95% CI -2.47 to -0.88).
CONCLUSIONS
Preterm infants ventilated using VTV modes had reduced duration of mechanical ventilation, incidence of BPD, failure of primary mode of ventilation, hypocarbia, grade 3/4 IVH, pneumothorax and PVL compared with preterm infants ventilated using PLV modes. There was no evidence that infants ventilated with VTV modes had reduced death compared to infants ventilated using PLV modes.
Topics: Bronchopulmonary Dysplasia; Humans; Incidence; Infant; Infant, Newborn; Positive-Pressure Respiration; Respiratory Distress Syndrome, Newborn; Tidal Volume
PubMed: 24277660
DOI: 10.1136/archdischild-2013-304613 -
The Cochrane Database of Systematic... Sep 2017Cerebral injury and long-term neurodevelopmental impairment is common in extremely preterm infants. Cerebral near-infrared spectroscopy (NIRS) enables continuous... (Review)
Review
BACKGROUND
Cerebral injury and long-term neurodevelopmental impairment is common in extremely preterm infants. Cerebral near-infrared spectroscopy (NIRS) enables continuous estimation of cerebral oxygenation. This diagnostic method coupled with appropriate interventions if NIRS is out of normal range (that is cerebral oxygenation within the 55% to 85% range) may offer benefits without causing more harms. Therefore, NIRS coupled with appropriate responses to abnormal findings on NIRS needs assessment in a systematic review of randomised clinical trials and quasi-randomised studies.
OBJECTIVES
To evaluate the benefits and harms of interventions that attempt to alter cerebral oxygenation guided by cerebral NIRS monitoring in order to prevent cerebral injury, improve neurological outcome, and increase survival in preterm infants born more than 8 weeks preterm.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2016, Issue 8), MEDLINE via PubMed (1966 to 10 September 2016), Embase (1980 to 10 September 2016), and CINAHL (1982 to 10 September 2016). We also searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised clinical trials and quasi-randomised studies.
SELECTION CRITERIA
Randomised clinical trials and quasi-randomised clinical studies comparing continuous cerebral NIRS monitoring for at least 24 hours versus blinded NIRS or versus no NIRS monitoring.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected, assessed the quality of, and extracted data from the included trials and studies. If necessary, we contacted authors for further information. We conducted assessments of risks of bias; risks of design errors; and controlled the risks of random errors with Trial Sequential Analysis. We assessed the quality of the evidence with GRADE.
MAIN RESULTS
One randomised clinical trial met inclusion criteria, including infants born more than 12 weeks preterm. The trial employed adequate methodologies and was assessed at low risk of bias. One hundred and sixty-six infants were randomised to start continuous cerebral NIRS monitoring less than 3 hours after birth until 72 hours after birth plus appropriate interventions if NIRS was out of normal range according to a guideline versus conventional monitoring with blinded NIRS. There was no effect of NIRS plus guideline of mortality until term-equivalent age (RR 0.50, 95% CI 0.29 to 1.00; one trial; 166 participants). There were no effects of NIRS plus guideline on intraventricular haemorrhages: all grades (RR 0.93, 95% CI 0.65 to 1.34; one trial; 166 participants); grade III/IV (RR 0.57, 95% CI 0.25 to 1.31; one trial; 166 participants); and cystic periventricular leukomalacia (which did not occur in either group). Likewise, there was no effect of NIRS plus guideline on the occurrence of a patent ductus arteriosus (RR 1.96, 95% CI 0.94 to 4.08; one trial; 166 participants); chronic lung disease (RR 1.27, 95% CI 0.94 to 1.50; one trial; 166 participants); necrotising enterocolitis (RR 0.83, 95% CI 0.33 to 1.94; one trial; 166 participants); and retinopathy of prematurity (RR 1.64, 95% CI 0.75 to 3.00; one trial; 166 participants). There were no serious adverse events in any of the intervention groups. NIRS plus guideline caused more skin marks from the NIRS sensor in the control group than in the experimental group (unadjusted RR 0.31, 95% CI 0.10 to 0.92; one trial; 166 participants). There are no data regarding neurodevelopmental outcome, renal impairment or air leaks.The quality of evidence for all comparisons discussed above was assessed as very low apart from all-cause mortality and adverse events: these were assessed as low and moderate, respectively. The validity of all comparisons is hampered by a small sample of randomised infants, risk of bias due to lack of blinding, and indirectness of outcomes.
AUTHORS' CONCLUSIONS
The only eligible randomised clinical trial did not demonstrate any consistent effects of NIRS plus a guideline on the assessed clinical outcomes. The trial was, however, only powered to detect difference in cerebral oxygenation, not morbidities or mortality. Our systematic review did not reach sufficient power to prove or disprove effects on clinical outcomes. Further randomised clinical trials with low risks of bias and low risks of random errors are needed.
Topics: Brain; Brain Injuries; Humans; Infant, Extremely Premature; Infant, Newborn; Oxygen Consumption; Randomized Controlled Trials as Topic; Spectroscopy, Near-Infrared
PubMed: 28869278
DOI: 10.1002/14651858.CD011506.pub2