A randomised trial of placing preterm infants on their back or left side after birth

Stenke, Emily; Kieran, Emily A; McCarthy, Laura; Dawson, Jennifer A; Vonderen, Jeroen J van; Kamlin, C. Omar F.; Davis, Peter G; Pas, Arjan B. te; O’Donnell, Colm P.

doi:10.1136/archdischild-2015-309842

Cited by 7 publications

(4 citation statements)

References 20 publications

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“…Although bench tests (36–38) imply that the Benveniste valve™ reduces the work of breathing, the clinical relevance of this finding is unknown. Infants were also positioned differently (supine vs. lateral on the right side), although no differences in oxygenation and heart rate were previously detected when comparing left-sided and supine positions (39). As the respiratory function monitor is mostly used in infants born by cesarean section at the University Hospital of Cologne, most infants in the high-pressure group were delivered by cesarean section.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Two Respiratory Support Strategies for Stabilization of Very Preterm Infants at Birth: A Matched-Pairs Analysis

et al. 2019

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Objective: Respiratory support for stabilizing very preterm infants at birth varies between centers. We retrospectively compared two strategies that involved either increasing continuous positive airway pressures (CPAP), or increasing oxygen supplementation.Methods: Matched-pairs of infants (<28 weeks of gestation) were born either at the Leiden University Medical Center [low-pressure: CPAP 5–8 cmH2O and/or positive pressure ventilation (PPV) and fraction of inspired oxygen (FiO2) 0.3–1.0; n = 27], or at the University Hospital of Cologne (high-pressure: CPAP 12–35 cmH2O, no PPV and FiO2 0.3–0.4; n = 27). Respiratory support was initiated non-invasively via facemask at both units. Infants (n = 54) were matched between centers for gestational age and birth weight, to compare physiological and short-term clinical outcomes.Results: In the low-pressure group, 20/27 (74%) infants received 1–2 sustained inflations (20, 25 cm H2O) and 22/27 (81%) received PPV (1:19–3:01 min) using pressures of 25–27 cm H2O. Within 3 min of birth [median (IQR)], mean airway pressures [12 (6–15) vs. 19 (16–23) cmH2O, p < 0.001] and FiO2 [0.30 (0.28–0.31) vs. 0.22 (0.21–0.30), p < 0.001] were different in low- vs. high-pressure groups, respectively. SpO2 and heart rates were similar. After 3 min, higher FiO2 levels [0.62 (0.35–0.98) vs. 0.28 (0.22–0.38), p = 0.005] produced higher SpO2 levels [77 (50–92) vs. 53 (42–69)%, p < 0.001] in the low-pressure group, but SpO2/FiO2 and heart rates were similar. While intubation rates during admission were significantly different (70 vs. 30%, p = 0.013), pneumothorax rates (4 vs. 19%, p = 0.125) and the occurrence of spontaneous intestinal perforations (0 vs. 15%, p = 0.125) were similar between groups.Conclusion: Infants (<28 weeks) can be supported non-invasively at birth with either higher or lower pressures and while higher-pressure support may require less oxygen, it does not eliminate the need for oxygen supplementation. Future studies need to examine the effect of high pressures and pressure titration in the delivery room.

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Section: Discussionmentioning

confidence: 99%

Comparison of Two Respiratory Support Strategies for Stabilization of Very Preterm Infants at Birth: A Matched-Pairs Analysis

et al. 2019

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“…Though the enrolment rates to our studies among eligible infants are consistently excellent (>80%), we believe it is necessary to enrol infants at multiple sites in order to enrol our planned target sample of 250 infants in a timely fashion. We have a track record enlisting the help of collaborators nationally 53 and internationally 54 55 to perform our studies. We believe that with their help, we can enrol these infants in 3 years.…”

Section: Methodsmentioning

confidence: 99%

Study protocol for the POPART study—Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial

et al. 2020

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IntroductionMany preterm infants develop respiratory distress syndrome (RDS), a condition characterised by a relative lack of surfactant. Endotracheal surfactant therapy revolutionised the care of preterm infants in the 1990s. However, supporting newborns with RDS with continuous positive airway pressure (CPAP) and reserving endotracheal surfactant for those who develop respiratory failure despite CPAP yield better results than intubating all infants for surfactant. Half of preterm infants born before 29 weeks gestation initially managed with CPAP are intubated for surfactant. Intubation is difficult to learn and associated with adverse effects. Surfactant administration into the oropharynx has been reported in preterm animals and humans and may be effective. We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.Methods and analysisProphylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial (POPART, Eudract No. 2016-004198-41) is an investigator-led, unblinded, multicentre, randomised, parallel group, controlled trial. Infants are eligible if born at a participating centre before 29 weeks gestational age (GA) and there is a plan to offer intensive care. Infants are excluded if they have major congenital anomalies. Infants are randomised at birth to treatment with oropharyngeal surfactant (120 mg vial <26 weeks GA stratum; 240 mg vial 26–28+6 weeks GA stratum) in addition to CPAP or CPAP alone. The primary outcome is intubation within 120 hours of birth, for bradycardia and/or apnoea despite respiratory support in the delivery room or respiratory failure in the intensive care unit. Secondary outcomes include incidence of mechanical ventilation, endotracheal surfactant use, chronic lung disease and death before hospital discharge.Ethics and disseminationApproval for the study has been granted by the Research Ethics Committees at the National Maternity Hospital, Dublin, Ireland (EC31.2016) and at each participating site. The trial is being conducted at nine centres in six European countries. The study results will be submitted for publication in a peer-reviewed journal.Trial registration number2016-004198-41; Pre-results.

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“…We need to consider alternative approaches to consent. Deferred consent—where subjects are enrolled and as soon as is reasonably possible, the patient’s family are informed of their inclusion, advised of the option to withdraw and their consent for continued participation is sought—has been used successfully in DR trials 22–25. Trials should meet certain criteria to be eligible for a deferred consent process.…”

Section: Recommendationsmentioning

confidence: 99%

Future of clinical trials in the delivery room: time for pragmatism

O’Donnell

Dekker

Rüdiger

et al. 2022

Arch Dis Child Fetal Neonatal Ed

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Despite increased amounts of research, most of the evidence that supports treatment of newborns in the delivery room is rated ‘low’ rather than ‘high’ quality. This assessment stems largely from a lack of evidence from clinical trials. When trials have been performed, the evidence has often been downgraded due to enrolment of small or poorly representative samples, and for lack of blinding of caregivers and outcome assessors. Delivery room trials present particular challenges when obtaining consent, enrolling participants, taking measures to limit bias and identifying appropriate outcome measures. We hope our suggestions as to how future delivery room trials could be more pragmatic will inform the design of large studies that are necessary to allow clinical practice to evolve.

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A randomised trial of placing preterm infants on their back or left side after birth

Abstract: ISRCTN74486341.

Cited by 7 publications

References 20 publications

Comparison of Two Respiratory Support Strategies for Stabilization of Very Preterm Infants at Birth: A Matched-Pairs Analysis

Comparison of Two Respiratory Support Strategies for Stabilization of Very Preterm Infants at Birth: A Matched-Pairs Analysis

Study protocol for the POPART study—Prophylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial

Future of clinical trials in the delivery room: time for pragmatism

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