Parallel Exploratory RCT of Polyethylene Wrap for Heat Loss Prevention in Infants Born at Less than 24 Weeks’ Gestation

Reilly, Maureen; Vohra, Sunita; Rac, Valeria E.; Zayack, Denise; Wimmer, John; Vincer, Michael; Ferrelli, Karla; Kiss, Alex; Soll, Roger F.; Dunn, Michael

doi:10.1159/000497253

Cited by 7 publications

(16 citation statements)

References 16 publications

(10 reference statements)

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“…A total of 6154 titles and abstracts were screened, of which 34 studies that enrolled 3688 neonates were included (eFigure 1 in the Supplement). Among the 34 studies were 4 three-armed RCTs . The mean gestational age of the neonates was 29 weeks, and their mean birth weight was 1200 g (eFigures 2 and 3 in the Supplement).…”

Section: Resultsmentioning

confidence: 99%

“…Thirty-two studies (94%), which involved 3568 neonates, reported the primary outcome of core body (axillary or rectal) temperature at admission or within 2 hours of life . Eight interventions, including routine care, were evaluated in these 32 studies.…”

Section: Resultsmentioning

confidence: 99%

“…This finding could be attributed to an increase in statistical power by the addition of evidence from the indirect fraction as well as the inclusion of 9 additional studies in this network meta-analysis. 24,25,36,37,[43][44][45][46]48,51 Because the various thermal care interventions have different mechanisms of action for preventing heat loss, using a combination of interventions might be beneficial for the most vulnerable neonates. SUCRA ranked plastic bag or wrap with a thermal mattress as the best intervention for improving core body temperature at admission or within 2 hours of life.…”

Section: Discussionmentioning

confidence: 99%

“…Thirty-two studies (94%), which involved 3568 neonates, reported the primary outcome of core body (axillary or rectal) temperature at admission or within 2 hours of life. 24,25,[27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][45][46][47][48][49][50][51][52][53][54][55][56][57] Eight interventions, including routine care, were evaluated in these 32 studies. Figure 1 shows the network plot, SUCRA plot, and forest plot with routine care as the common comparator.…”

Section: Primary Outcomesmentioning

confidence: 99%

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Delivery Room Interventions for Hypothermia in Preterm Neonates

et al. 2021

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IMPORTANCE Prevention of hypothermia in the delivery room is a cost-effective, high-impact intervention to reduce neonatal mortality, especially in preterm neonates. Several interventions for preventing hypothermia in the delivery room exist, of which the most beneficial is currently unknown. OBJECTIVE To identify the delivery room thermal care intervention that can best reduce neonatal hypothermia and improve clinical outcomes for preterm neonates born at 36 weeks' gestation or less.DATA SOURCES MEDLINE, the Cochrane Central Register of Controlled Trials, Embase, and CINAHL databases were searched from inception to November 5, 2020.STUDY SELECTION Randomized and quasi-randomized clinical trials of thermal care interventions in the delivery room for preterm neonates were included. Peer-reviewed abstracts and studies published in non-English language were also included.DATA EXTRACTION AND SYNTHESIS Data from the included trials were extracted in duplicate using a structured proforma. A network meta-analysis with bayesian random-effects model was used for data synthesis.MAIN OUTCOMES AND MEASURES Primary outcomes were core body temperature and incidence of moderate to severe hypothermia on admission or within the first 2 hours of life. Secondary outcomes were incidence of hyperthermia, major brain injury, and mortality before discharge. The 9 thermal interventions evaluated were (1) plastic bag or plastic wrap covering the torso and limbs with the head uncovered or covered with a cloth cap; (2) plastic cap covering the head; (3) skin-to-skin contact; (4) thermal mattress; (5) plastic bag or plastic wrap with a plastic cap; (6) plastic bag or plastic wrap along with use of a thermal mattress; (7) plastic bag or plastic wrap along with heated humidified gas for resuscitation or for initiating respiratory support in the delivery room; (8) plastic bag or plastic wrap along with an incubator for transporting from the delivery room; and (9) routine care, including drying and covering the body with warm blankets, with or without a cloth cap. RESULTSOf the 6154 titles and abstracts screened, 34 studies that enrolled 3688 neonates were analyzed. Compared with routine care alone, plastic bag or wrap with a thermal mattress (mean difference [MD], 0.98 °C; 95% credible interval [CrI], 0.60-1.36 °C), plastic cap (MD, 0.83 °C; 95% CrI, 0.28-1.38 °C), plastic bag or wrap with heated humidified respiratory gas (MD, 0.76 °C; 95% CrI, 0.38-1.15 °C), plastic bag or wrap with a plastic cap (MD, 0.62 °C; 95% CrI, 0.37-0.88 °C), thermal mattress (MD, 0.62 °C; 95% CrI, 0.33-0.93 °C), and plastic bag or wrap (MD, 0.56 °C; 95% CrI, 0.44-0.69 °C) were associated with greater core body temperature. Certainty of evidence was moderate for 5 interventions and low for plastic bag or wrap with a thermal mattress. When compared with routine care alone, a plastic bag or wrap with heated humidified respiratory gas was associated with less risk of major brain injury (risk ratio, 0.23; 95% CrI, 0.03-0.67; moderate certainty of evidence) and a plastic ...

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Primary Outcomesmentioning

confidence: 99%

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Delivery Room Interventions for Hypothermia in Preterm Neonates

et al. 2021

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“…Abou et al 52 ".for 22-23 + 6 we do resuscitation in some cases based on an internal pathway and guidelines looking at maternal history and the best interest of that fetus/baby (limits of viability pathway and guidelines); thus we decided to exclude, as not all would receive resuscitation." Reilly et al 228 "Our decision to exclude these infants £23 weeks of gestation. from the main study was because of their much higher mortality rate (mortality was our primary outcome).…”

Section: Discussionmentioning

confidence: 99%

Eligibility Criteria and Representativeness of Randomized Clinical Trials That Include Infants Born Extremely Premature: A Systematic Review

Pavlek

Rivera

Smith³

et al. 2021

The Journal of Pediatrics

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Objective To assess the eligibility criteria and trial characteristics among contemporary (2010)(2011)(2012)(2013)(2014)(2015)(2016)(2017)(2018)(2019) randomized clinical trials (RCTs) that included infants born extremely preterm (<28 weeks of gestation) and to evaluate whether eligibility criteria result in underrepresentation of high-risk subgroups (eg, infants born at <24 weeks of gestation).Study design PubMed and Scopus were searched January 1, 2010, to December 31, 2019, with no language restrictions. RCTs with mean or median gestational ages at birth of <28 weeks of gestation were included. The study followed the PRISMA guidelines; outcomes were registered prospectively. Data extraction was performed independently by multiple observers. Study quality was evaluated using a modified Jadad scale.Results Among RCTs (n = 201), 32 552 infants were included. Study participant characteristics, interventions, and outcomes were highly variable. A total of 1603 eligibility criteria were identified; rationales were provided for 18.8% (n = 301) of criteria. Fifty-five RCTs (27.4%) included infants <24 weeks of gestation; 454 (1.4%) infants were identified as <24 weeks of gestation.Conclusions The present study identifies sources of variability across RCTs that included infants born extremely preterm and reinforces the critical need for consistent and transparent policies governing eligibility criteria.

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