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JPMA. the Journal of the Pakistan... Oct 2022The management of patent ductus arteriosus (PDA) in preterm neonates remains controversial. A retrospective review was conducted to determine the outcomes in preterm...
The management of patent ductus arteriosus (PDA) in preterm neonates remains controversial. A retrospective review was conducted to determine the outcomes in preterm neonates with PDA. Data of neonates admitted to the Aga Khan University Hospital from January 2012 to December 2016 were retrieved from patient records. Of the 208 neonates included in the study, 143 (68.7%) received no treatment, while 65 (31.2%) underwent pharmacotherapy and/or surgical ligation for PDA closure. PDA closure was spontaneous in 109 (52.4%) neonates. The mean ±SD gestational age (GA) of neonates with spontaneous ductal closure was greater as compared to those who required some form of treatment [33±3.3 vs 29.7±3.1weeks, p=0.001]. Apnoea (OR:4.47; 95% CI:1.21-16.44), sepsis (OR:3.81; 95% CI:1.33-10.87), pulmonary haemorrhage (OR:4.88; 95% CI:1.24-19.19), and lower APGAR (OR:0.69; 95% CI:0.54-0.90) were associated with higher odds of mortality in our cohort. Our findings demonstrate that PDA resolves spontaneously in most preterm neonates and provide evidence that conservative treatment is not associated with mortality.
Topics: Humans; Infant, Newborn; Ductus Arteriosus, Patent; Gestational Age; Infant, Premature; Retrospective Studies; Tertiary Care Centers; Treatment Outcome
PubMed: 36660997
DOI: 10.47391/JPMA.3416 -
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 -
The Cochrane Database of Systematic... Jan 2020In preterm newborns, the ductus arteriosus frequently fails to close and the infants require medical or surgical closure of the patent ductus arteriosus (PDA). A PDA can... (Meta-Analysis)
Meta-Analysis
BACKGROUND
In preterm newborns, the ductus arteriosus frequently fails to close and the infants require medical or surgical closure of the patent ductus arteriosus (PDA). A PDA can be treated surgically; or medically with one of two prostaglandin inhibitors, indomethacin or ibuprofen. Case reports suggest that paracetamol may be an alternative for the closure of a PDA. An association between prenatal or postnatal exposure to paracetamol and later development of autism or autism spectrum disorder has been reported.
OBJECTIVES
To determine the effectiveness and safety of intravenous or oral paracetamol compared with placebo or no intervention, intravenous indomethacin, intravenous or oral ibuprofen, or with other cyclo-oxygenase inhibitors for treatment of an echocardiographically diagnosed PDA in preterm or low birth weight infants.
SEARCH METHODS
We used the standard search strategy of Cochrane Neonatal to search the Cochrane Central Register of Controlled Trials (CENTRAL 2017, Issue 10), MEDLINE via PubMed (1966 to 6 November 2017), Embase (1980 to 6 November 2017), and CINAHL (1982 to 6 November 2017). We searched clinical trial databases, conference proceedings, and the reference lists of retrieved articles for randomised controlled trials (RCT) and quasi-randomised trials.
SELECTION CRITERIA
We included RCTs in which paracetamol was compared to no intervention, placebo or other agents used for closure of PDA irrespective of dose, duration and mode of administration in preterm (≤ 34 weeks' postmenstrual age) infants. We both reviewed the search results and made a final selection of potentially eligible articles by discussion. We included studies of both prophylactic and therapeutic use of paracetamol.
DATA COLLECTION AND ANALYSIS
We performed data collection and analyses in accordance with the methods of the Cochrane Neonatal Review Group. We used the GRADE approach to assess the quality of evidence for the following outcomes when data were available: failure of ductal closure after the first course of treatment; neurodevelopmental impairment; all-cause mortality during initial hospital stay (death); gastrointestinal bleed or stools positive for occult blood; and serum levels of creatinine after treatment (µmol/L).
MAIN RESULTS
We included eight studies that reported on 916 infants. One of these studies compared paracetamol to both ibuprofen and indomethacin. Five studies compared treatment of PDA with paracetamol versus ibuprofen and enrolled 559 infants. There was no significant difference between paracetamol and ibuprofen for failure of ductal closure after the first course of drug administration (typical risk ratio (RR) 0.95, 95% confidence interval (CI) 0.75 to 1.21; typical risk difference (RD) -0.02, 95% CI -0.09 to 0.09); I² = 0% for RR and RD; moderate quality of evidence. Four studies (n = 537) reported on gastrointestinal bleed which was lower in the paracetamol group versus the ibuprofen group (typical RR 0.28, 95% CI 0.12 to 0.69; typical RD -0.06, 95% CI -0.09 to -0.02); I² = 0% for RR and RD; number needed to treat for an additional beneficial outcome (NNTB) 17 (95% CI 11 to 50); moderate quality of evidence. The serum levels of creatinine were lower in the paracetamol group compared with the ibuprofen group in four studies (moderate quality of evidence), as were serum bilirubin levels following treatment in two studies (n = 290). Platelet counts and daily urine output were higher in the paracetamol group compared with the ibuprofen group. One study reported on long-term follow-up to 18 to 24 months of age following treatment with paracetamol versus ibuprofen. There were no significant differences in the neurological outcomes at 18 to 24 months (n = 61); (low quality of evidence). Two studies compared prophylactic administration of paracetamol for a PDA with placebo or no intervention in 80 infants. Paracetamol resulted in a lower rate of failure of ductal closure after 4 to 5 days of treatment compared to placebo or no intervention which was of borderline significance for typical RR 0.49 (95% CI 0.24 to 1.00; P = 0.05); but significant for typical RD -0.21 (95% CI -0.41 to -0.02); I² = 0 % for RR and RD; NNTB 5 (95% CI 2 to 50); (low quality of evidence). Two studies (n = 277) compared paracetamol with indomethacin. There was no significant difference in the failure to close a PDA (typical RR 0.96, 95% CI 0.55 to 1.65; I² = 11%; typical RD -0.01, 95% CI -0.09 to 0.08; I² = 17%) (low quality of evidence). Serum creatinine levels were significantly lower in the paracetamol group compared with the indomethacin group and platelet counts and daily urine output were significantly higher in the paracetamol group.
AUTHORS' CONCLUSIONS
Moderate-quality evidence according to GRADE suggests that paracetamol is as effective as ibuprofen; low-quality evidence suggests paracetamol to be more effective than placebo or no intervention; and low-quality evidence suggests paracetamol as effective as indomethacin in closing a PDA. There was no difference in neurodevelopmental outcome in children exposed to paracetamol compared to ibuprofen; however the quality of evidence is low and comes from only one study. In view of concerns raised regarding neurodevelopmental outcomes following prenatal and postnatal exposure to paracetamol, long-term follow-up to at least 18 to 24 months' postnatal age must be incorporated in any studies of paracetamol in the newborn population. At least 19 ongoing trials have been registered. Such trials are required before any recommendations for the possible routine use of paracetamol in the newborn population can be made.
Topics: Acetaminophen; Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Odds Ratio; Randomized Controlled Trials as Topic
PubMed: 31985831
DOI: 10.1002/14651858.CD010061.pub4 -
The Cochrane Database of Systematic... Nov 2023Many preterm infants require respiratory support to maintain an optimal level of oxygenation, as oxygen levels both below and above the optimal range are associated with... (Review)
Review
BACKGROUND
Many preterm infants require respiratory support to maintain an optimal level of oxygenation, as oxygen levels both below and above the optimal range are associated with adverse outcomes. Optimal titration of oxygen therapy for these infants presents a major challenge, especially in neonatal intensive care units (NICUs) with suboptimal staffing. Devices that offer automated oxygen delivery during respiratory support of neonates have been developed since the 1970s, and individual trials have evaluated their effectiveness.
OBJECTIVES
To assess the benefits and harms of automated oxygen delivery systems, embedded within a ventilator or oxygen delivery device, for preterm infants with respiratory dysfunction who require respiratory support or supplemental oxygen therapy.
SEARCH METHODS
We searched CENTRAL, MEDLINE, CINAHL, and clinical trials databases without language or publication date restrictions on 23 January 2023. We also checked the reference lists of retrieved articles for other potentially eligible trials.
SELECTION CRITERIA
We included randomised controlled trials and randomised cross-over trials that compared automated oxygen delivery versus manual oxygen delivery, or that compared different automated oxygen delivery systems head-to-head, in preterm infants (born before 37 weeks' gestation).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our main outcomes were time (%) in desired oxygen saturation (SpO) range, all-cause in-hospital mortality by 36 weeks' postmenstrual age, severe retinopathy of prematurity (ROP), and neurodevelopmental outcomes at approximately two years' corrected age. We expressed our results using mean difference (MD), standardised mean difference (SMD), and risk ratio (RR) with 95% confidence intervals (CIs). We used GRADE to assess the certainty of evidence.
MAIN RESULTS
We included 18 studies (27 reports, 457 infants), of which 13 (339 infants) contributed data to meta-analyses. We identified 13 ongoing studies. We evaluated three comparisons: automated oxygen delivery versus routine manual oxygen delivery (16 studies), automated oxygen delivery versus enhanced manual oxygen delivery with increased staffing (three studies), and one automated system versus another (two studies). Most studies were at low risk of bias for blinding of personnel and outcome assessment, incomplete outcome data, and selective outcome reporting; and half of studies were at low risk of bias for random sequence generation and allocation concealment. However, most were at high risk of bias in an important domain specific to cross-over trials, as only two of 16 cross-over trials provided separate outcome data for each period of the intervention (before and after cross-over). Automated oxygen delivery versus routine manual oxygen delivery Automated delivery compared with routine manual oxygen delivery probably increases time (%) in the desired SpO range (MD 13.54%, 95% CI 11.69 to 15.39; I = 80%; 11 studies, 284 infants; moderate-certainty evidence). No studies assessed in-hospital mortality. Automated oxygen delivery compared to routine manual oxygen delivery may have little or no effect on risk of severe ROP (RR 0.24, 95% CI 0.03 to 1.94; 1 study, 39 infants; low-certainty evidence). No studies assessed neurodevelopmental outcomes. Automated oxygen delivery versus enhanced manual oxygen delivery There may be no clear difference in time (%) in the desired SpO range between infants who receive automated oxygen delivery and infants who receive manual oxygen delivery (MD 7.28%, 95% CI -1.63 to 16.19; I = 0%; 2 studies, 19 infants; low-certainty evidence). No studies assessed in-hospital mortality, severe ROP, or neurodevelopmental outcomes. Revised closed-loop automatic control algorithm (CLACfast) versus original closed-loop automatic control algorithm (CLACslow) CLACfast allowed up to 120 automated adjustments per hour, whereas CLACslow allowed up to 20 automated adjustments per hour. CLACfast may result in little or no difference in time (%) in the desired SpO range compared to CLACslow (MD 3.00%, 95% CI -3.99 to 9.99; 1 study, 19 infants; low-certainty evidence). No studies assessed in-hospital mortality, severe ROP, or neurodevelopmental outcomes. OxyGenie compared to CLiO Data from a single small study were presented as medians and interquartile ranges and were not suitable for meta-analysis.
AUTHORS' CONCLUSIONS
Automated oxygen delivery compared to routine manual oxygen delivery probably increases time in desired SpO ranges in preterm infants on respiratory support. However, it is unclear whether this translates into important clinical benefits. The evidence on clinical outcomes such as severe retinopathy of prematurity are of low certainty, with little or no differences between groups. There is insufficient evidence to reach any firm conclusions on the effectiveness of automated oxygen delivery compared to enhanced manual oxygen delivery or CLACfast compared to CLACslow. Future studies should include important short- and long-term clinical outcomes such as mortality, severe ROP, bronchopulmonary dysplasia/chronic lung disease, intraventricular haemorrhage, periventricular leukomalacia, patent ductus arteriosus, necrotising enterocolitis, and long-term neurodevelopmental outcomes. The ideal study design for this evaluation is a parallel-group randomised controlled trial. Studies should clearly describe staffing levels, especially in the manual arm, to enable an assessment of reproducibility according to resources in various settings. The data of the 13 ongoing studies, when made available, may change our conclusions, including the implications for practice and research.
Topics: Humans; Infant; Infant, Newborn; Bronchopulmonary Dysplasia; Infant, Premature; Oxygen; Randomized Controlled Trials as Topic; Reproducibility of Results; Retinopathy of Prematurity
PubMed: 38032241
DOI: 10.1002/14651858.CD013294.pub2 -
Frontiers in Pharmacology 2022Retinopathy of prematurity (ROP) is a major cause of childhood blindness. Antenatal corticosteroids (ACS) exposure is known to ameliorate the risk of and mortality of... (Review)
Review
Retinopathy of prematurity (ROP) is a major cause of childhood blindness. Antenatal corticosteroids (ACS) exposure is known to ameliorate the risk of and mortality of neonatal morbidities. However, the effect of ACS on ROP development is currently unknown. We conducted a meta-analysis with up-to-date evidence to assess the association between ACS exposure and the development of ROP in at-risk preterm infants. PubMed, EMBASE, Scopus, Web of Science, and the Cochrane Library were systematically searched from inception to May 2021, supplemented with manual search from reference lists. Studies with a control group reporting ROP rate in ACS-exposed infants were included. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated utilizing a random-effects model. The Newcastle-Ottawa Scale was used for assessment of risk of bias in the included studies. Meta-regressions were performed to explore the predictive role of confounders for between-study variance. A total of 63 studies, involving 196,264 infants, were included. Meta-analysis showed ACS exposure was not associated with ROP occurrence (uOR 0.92, 95% CI 0.80-1.07; aOR 0.87, 95% CI 0.7-1.08). Results from extremely immature subgroups revealed significant reduced risks of ROP occurrence in ACS-exposed infants. ACS exposure was associated with significantly lower odds of ROP progression in adjusted analysis (aOR 0.48, 95% CI 0.26-0.89) instead of unadjusted analysis (uOR 0.86, 95% CI 0.68-1.08). Meta-regression showed birth weight and patent ductus arteriosus of the cohort were associated with ROP occurrence, sample size and study design strongly associated with ROP progression in ACS-exposed infants. ACS treatment may decrease, but not prevent, the severity of ROP. Findings from severe ROP should be interpreted with caution owing to limited studies and the possibility of false-positive results. Considering the particular benefits in extremely immature infants, we recommend routine usage of ACS in mothers with threatened delivery to this particular birth cohort to prevent ROP occurrence. Future studies adjusting for major confounders are warranted to mitigate risk of bias in such observational evidence.
PubMed: 35153772
DOI: 10.3389/fphar.2022.759742 -
BMC Cardiovascular Disorders Jan 2021Both systemic-pulmonary shunt and arterial duct stent could be the palliation of duct-dependent pulmonary circulation. We aimed to compare the safety and efficacy of the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Both systemic-pulmonary shunt and arterial duct stent could be the palliation of duct-dependent pulmonary circulation. We aimed to compare the safety and efficacy of the two approaches.
METHODS
The PubMed, EMBASE, and Cochrane Library databases were searched through December 2019 for studies comparing stent implantation and surgical shunt in duct-dependent pulmonary circulation. The baseline characteristics included ventricle physiology and cardiac anomaly. The main outcomes were hospital stay and total mortality. Additional outcomes included procedural complications, intensive care unit (ICU) stay, pulmonary artery growth at follow-up, and other indexes. A random- or fixed-effects model was used to summarize the estimates of the mean difference (MD)/risk ratio (RR) with 95% confidence intervals (CIs).
RESULTS
In total, 757 patients with duct-dependent pulmonary circulation from six studies were included. Pooled estimates of hospital stay (MD, - 4.83; 95% CI - 7.92 to - 1.74; p < 0.05), total mortality (RR 0.44; 95% CI 0.28-0.70; p < 0.05), complications (RR 0.49; 95% CI 0.30-0.81; p < 0.05) and ICU stay (MD, - 4.00; 95% CI - 5.96 to - 2.04; p < 0.05) favored the stent group. Significant differences were found in the proportions of patients with a single ventricle (RR 0.82; 95% CI 0.68-0.98; p < 0.05) or a double ventricle (RR 1.23; 95% CI 1.07-1.41; p < 0.05) between the stent and shunt groups. Additionally, pulmonary artery growth showed no significant differences between the two groups.
CONCLUSION
Arterial duct stent appears to have not inferior outcomes of procedural complications, mortality, hospital and ICU stay, and pulmonary artery growth in selected patients compared with a surgical shunt.
TRIAL REGISTRATION
CRD42019147672.
Topics: Blalock-Taussig Procedure; Cardiac Catheterization; Child; Child, Preschool; Ductus Arteriosus, Patent; Female; Heart Defects, Congenital; Hemodynamics; Humans; Infant; Infant, Newborn; Length of Stay; Male; Palliative Care; Pulmonary Artery; Pulmonary Circulation; Recovery of Function; Stents; Time Factors; Treatment Outcome
PubMed: 33407150
DOI: 10.1186/s12872-020-01817-2 -
European Archives of... Dec 2022This systematic review aims to provide an overview of the current evidence-base for paediatric surgical reinnervation in unilateral and bilateral vocal fold palsies in... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review aims to provide an overview of the current evidence-base for paediatric surgical reinnervation in unilateral and bilateral vocal fold palsies in clinical practice. We aim to assess patient demographics, surgical technique and pre- and post-operative outcome measures.
METHODS
A systematic literature review was performed and reported according to international PRISMA recommendations. A comprehensive search of PubMed, Embase, and Cochrane CENTRAL databases for relevant publications for all available dates with appropriate MESH search criteria was performed. Articles were categorised by four authors independently. A pooled summative analysis was carried out to allow review of demographic and outcome data.
RESULTS
Our systematic PRISMA approach resulted in 19 papers being selected for inclusion and analysis with 179 patients undergoing reinnervation (153 unilateral, 26 bilateral). The youngest patient was 1.9 years. Iatrogenic injury to recurrent laryngeal nerve most common aetiology (65.4% and 19.2% of unilateral and bilateral vocal fold palsies, respectively). Patent ductus arteriosus ligation was the single most common procedure resulting in unilateral vocal fold palsies (43.1% of cases). Statistically significant improvements in subjective and objective outcomes for both voice and swallowing were seen. Meta-analysis was able to be performed on the particularly evident improvements in GRBAS score and Maximum Phonation Time (MPT). GRBAS scores improved by 3.64 (p < 0.01, 95% CI 2.65 to 4.63). MPT showed a statistically significant improvement of 5.26 s (p < 0.05, 95% CI 4.28 to 6.24). No major complications were reported.
CONCLUSION
The current published evidence on one-hundred and seventy-nine paediatric surgical reinnervation procedures demonstrates its role as a safe and effective treatment for both unilateral and bilateral vocal fold palsies. Anatomically it has been shown to improve vocal fold tone, bulk and position. Both post-operative voice and swallowing outcomes show improvement as well as associated quality of life measures.
Topics: Humans; Child; Vocal Cord Paralysis; Quality of Life; Recurrent Laryngeal Nerve; Vocal Cords; Larynx
PubMed: 35838782
DOI: 10.1007/s00405-022-07471-y -
Frontiers in Pediatrics 2021There is an ongoing debate on the optimal management of patent ductus arteriosus (PDA) in preterm infants. Identifying subgroup of infants who would benefit from...
There is an ongoing debate on the optimal management of patent ductus arteriosus (PDA) in preterm infants. Identifying subgroup of infants who would benefit from pharmacological treatment might help. To investigate the modulating effect of the differences in methodological quality, the rate of open-label treatment, and patient characteristics on relevant outcome measures in randomized controlled trials (RCTs). Electronic database search between 1950 and May 2020. RCTs that assessed pharmacological treatment compared to placebo/no treatment. Data is extracted following the PRISMA guidelines. Outcome measures were failure to ductal closure, surgical ligation, incidence of necrotizing enterocolitis, bronchopulmonary dysplasia, sepsis, periventricular leukomalacia, intraventricular hemorrhage (IVH) grade ≥3, retinopathy of prematurity and mortality. Forty-seven studies were eligible. The incidence of IVH grade ≥3 was lower in the treated infants compared to the placebo/no treatment (RR 0.77, 95% CI 0.64-0.94) and in the subgroups of infants with either a gestational age <28 weeks (RR 0.77, 95% CI 0.61-0.98), a birth weight <1,000 g (RR 0.77, 95% CI 0.61-0.97), or if untargeted treatment with indomethacin was started <24 h after birth (RR 0.70, 95% CI 0.54-0.90). Statistical heterogeneity caused by missing data and variable definitions of outcome parameters. Although the quality of evidence is low, this meta-analysis suggests that pharmacological treatment of PDA reduces severe IVH in extremely preterm, extremely low birth weight infants or if treatment with indomethacin was started <24 h after birth. No other beneficial effects of pharmacological treatment were found.
PubMed: 33634058
DOI: 10.3389/fped.2021.626262 -
Medicine Feb 2020Patent ductus arteriosus (PDA) is a particularly common problem in preterm infants. Although surgical ligation is rarely performed in many contemporary neonatal... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Patent ductus arteriosus (PDA) is a particularly common problem in preterm infants. Although surgical ligation is rarely performed in many contemporary neonatal intensive care units, it remains a necessary treatment option for preterm infants with a large hemodynamically significant PDA under strict clinical criteria, and it can reduce mortality in preterm infants. However, the optimal timing of surgical ligation is still controversial. We conducted this systematic review and meta-analysis to compare the mortality and morbidity of early and late surgical ligation of PDA in preterm or very-low-birth-weight (VLBW) infants.
METHODS
This review was registered in the International Prospective Register of Systematic Reviews (PROSPERO) (CRD42019133686). We searched the databases of PubMed, Embase, the Cochrane Central Register of Controlled Trials, and the World Health Organization International Clinical Trials Registry Platform up to May 2019.
RESULTS
This review included 6 retrospective studies involving 397 premature or VLBW infants with PDA. Pooled analysis showed that compared with the late ligation group, the early ligation group had a lower fraction of inspired oxygen (FiO2) at 24 hours postoperatively (mean difference [MD] -6.34, 95% confidence interval [CI] -9.45 to -3.22), fewer intubation days (MD -19.69, 95% CI -29.31 to -10.07), earlier date of full oral feeding (MD -22.98, 95% CI -28.63 to -17.34) and heavier body weight at 36 weeks of conceptional age (MD 232.08, 95% CI 57.28 to 406.88). No significant difference in mortality or other complications was found between the early and late groups.
CONCLUSION
Our meta-analysis implies that compared with late surgical ligation, early ligation might have a better respiratory outcome and nutritional status for PDA in preterm or VLBW infants. There was no difference in mortality or postoperative complications between early and late ligation. A randomized prospective clinical trial with a possible large sample size is urgently needed to reinvestigate this conclusion.
PROSPERO REGISTRATION NUMBER
CRD42019133686.
Topics: Ductus Arteriosus, Patent; Female; Humans; Infant; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Ligation; Male; Time Factors
PubMed: 32118777
DOI: 10.1097/MD.0000000000019356 -
Indian Heart Journal 2020This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of oral acetaminophen compared to oral ibuprofen for patent... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
This systematic review and meta-analysis aimed to synthesize the latest evidence on the efficacy and safety of oral acetaminophen compared to oral ibuprofen for patent ductus arteriosus (PDA) in preterm infants.
METHODS
We performed a systematic literature search on topics that assesses the use of oral paracetamol compared to oral ibuprofen in preterm neonates diagnosed with PDA from PubMed, EuropePMC, Cochrane Central Database, ScienceDirect, ProQuest, ClinicalTrials.gov, and hand-sampling from potential articles.
RESULTS
There were 1547 subjects from 10 selected studies. Primary closure rate was similar in both groups. Subgroup analysis on studies enrolling neonates with ≤30 weeks gestational age showed that ibuprofen was superior (OR 0.52 [0.31, 0.90], I: 0%). On the other hand, paracetamol was superior neonates with ≤34 weeks gestational age (OR 1.73 [1.01, 2.94], I: 30%). Reopening rate, surgical closure rate, mortality, intraventricular hemorrhage, and necrotizing enterocolitis were similar in both groups. Rate of renal dysfunction (OR 0.27 [0.10, 0.77], I: 0%) and gastrointestinal bleeding (OR 0.31 [0.11, 0.88], I: 0%) were lower in paracetamol group. Subgroup analysis of randomized controlled studies (RCTs) showed similar results. Meta-regression analysis showed that the primary closure rate was not influenced by gestational age, birth weight, and gender. GRADE demonstrates a low level of certainty for primary closure and mortality. Renal dysfunction and gastrointestinal bleeding havea moderate level of certainty.
CONCLUSION
There was no significant difference between the efficacy of oral paracetamol and oral ibuprofen. However, the rate of renal dysfunction and gastrointestinal bleeding were higher in oral ibuprofen.
Topics: Acetaminophen; Administration, Oral; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Cardiac Surgical Procedures; Ductus Arteriosus, Patent; Gestational Age; Humans; Ibuprofen; Infant, Newborn; Infant, Premature; Treatment Outcome
PubMed: 32768013
DOI: 10.1016/j.ihj.2020.05.012