CPAP for Premature Birth

(PLANT Trial)

Not currently recruiting at 7 trial locations

Overseen By Edgardo Szyld, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Congenital anomalies, Pulmonary hypoplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: First 30 minutes after birth

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using a breathing support called CPAP (Continuous Positive Airway Pressure) immediately after birth helps late preterm newborns (born between 34 and 37 weeks) breathe better and avoid additional respiratory support. The study compares babies receiving CPAP with those receiving the usual care without it. Newborns eligible for the trial are those born by C-section and breathing independently. The trial aims to determine if early CPAP can reduce the need for intensive care in these infants. As an unphased trial, this study provides a unique opportunity to contribute to important research that could improve care for future newborns.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Do I need to stop my current medications for this trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that Continuous Positive Airway Pressure is safe for late preterm newborns?

Research has shown that using Continuous Positive Airway Pressure (CPAP) early in newborns is safe and effective. One study found that starting CPAP soon after birth reduced the need for more invasive breathing support, like machines, by 45%. As a result, fewer babies required extra help to breathe.

Another study discovered that using CPAP longer in stable premature babies might aid lung growth and function. This suggests that newborns generally tolerate CPAP well.

While some research noted that CPAP didn't significantly reduce certain risks, such as death or lung problems, in very early preterm babies, it still revealed no major safety concerns. Overall, these findings suggest that CPAP is a safe option to help newborns breathe more easily right after birth. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for prophylactic delivery room Continuous Positive Airway Pressure (CPAP) for premature infants because it explores a proactive approach to supporting newborns' breathing right from birth. Unlike the standard of care, which involves using CPAP only when breathing difficulties become evident, this approach administers CPAP immediately to infants who are breathing spontaneously. This early intervention might help prevent respiratory issues before they escalate, potentially reducing complications and improving outcomes for premature babies. The trial aims to determine if this early, preventive use of CPAP can make a significant difference in the health of these vulnerable infants.

What evidence suggests that Continuous Positive Airway Pressure is effective for reducing NICU admissions in late preterm newborns?

Research has shown that using Continuous Positive Airway Pressure (CPAP) immediately after birth can help premature babies breathe better independently. In this trial, some infants will receive Prophylactic Delivery Room Continuous Positive Airway Pressure, which involves administering CPAP right after birth. Studies have found that starting CPAP early might reduce the need for more intense breathing support later. This treatment has been linked to fewer cases of bronchopulmonary dysplasia and a lower risk of death in very premature infants. Early CPAP can also reduce the need for mechanical ventilation, which is more invasive. Overall, early CPAP appears promising for improving breathing outcomes in premature newborns. ^{2 6 7 8 9}

Who Is on the Research Team?

Birju Shah, MD

Principal Investigator

Univeristy of Oklahoma Health Sciences Center

Are You a Good Fit for This Trial?

This trial is for late preterm infants born by C-section, specifically those with a gestational age between 34 and less than 37 weeks. Infants must be inborn (delivered at the hospital where the trial is conducted). Those with major congenital anomalies or conditions that severely limit life expectancy, such as pulmonary hypoplasia, cannot participate.

Inclusion Criteria

My newborn was delivered via Cesarean section.

My newborn was delivered via C-section between 34 and <37 weeks of pregnancy.

Gestational age between 34 weeks and < 37 weeks

Exclusion Criteria

Major congenital anomalies including pulmonary hypoplasia and lethal life-limiting conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or virtual)

Treatment

Neonates receive either prophylactic DR-CPAP or standard care immediately after birth

First 30 minutes after birth

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days or until hospital discharge

Ongoing in-hospital monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Positive Airway Pressure
• Prophylactic Delivery Room Continuous Positive Airway Pressure

Trial Overview The study tests if giving early prophylactic Continuous Positive Airway Pressure (CPAP), with or without extra oxygen, to spontaneously breathing late preterm infants can reduce the need for additional respiratory support and NICU admissions compared to not using early CPAP.

How Is the Trial Designed?

Group I: Prophylactic Delivery Room Continuous Positive Airway Pressure Experimental Treatment 1 Intervention

If the infant is spontaneously breathing and allocated to the experimental arm, s/he will receive 20 min of 5 cm H2O of prophylactic continuous airway pressure using either a face mask or the appropriate size of nasal prong.

Group II: No Prophylactic Delivery Room Continuous Positive Airway Pressure Active Control 1 Intervention

Alternatively, spontaneously breathing infants assigned to control group will receive the standard of care with no prophylactic delivery room continuous positive airway pressure (CPAP). In both groups, CPAP can be used to help babies with persistent labored breathing or cyanosis after the initial steps as per the participating institution's neonatal resuscitation protocol. At any time, if the patient does not present spontaneous breathing, an escalation on the resuscitation measures will be performed and the study intervention will be terminated.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Pontificia Universidad Catolica de Chile

Collaborator

Trials

221

Recruited

165,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

St. Louis University

Collaborator

Trials

197

Recruited

41,400+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Emphasizing risk management in pregnancy and childbirth can lead to providers controlling women's decisions, potentially making the process less safe for mothers and babies.

By accepting that no life is without risk, women can make informed choices based on real evidence, which can enhance safety for themselves and their babies during pregnancy and childbirth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk, safety, and choice in childbirth. Lothian, JA.[2021]

In a study of 340 ICU patients, 85.9% experienced at least one adverse event (AE) during nursing care procedures (NCP), highlighting the high incidence of AEs in critical care settings.

Severe adverse events (SAE) occurred in 5.5% of NCP, with pain and agitation identified as significant risk factors, suggesting that addressing these issues could help reduce the occurrence of AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during nursing care procedure in intensive care unit: The PREVENIR study. Lesny, M., Conrad, M., Latarche, C., et al.[2021]

In a meta-analysis of two randomized control trials involving 323 newborns, the use of continuous positive airway pressure (CPAP) in the delivery room significantly reduced the likelihood of NICU admissions and the need for respiratory support compared to no CPAP.

However, two before-after studies with 8,476 newborns indicated that using CPAP in the delivery room was associated with an increased risk of air leak syndrome, highlighting the need for caution and further research on its routine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure for term and &#8805;34+0 weeks' gestation newborns at birth: A systematic review. Shah, BA., Fabres, JG., Leone, TA., et al.[2022]

A new framework for monitoring adverse events (AEs) in pregnancy trials has been developed, which includes specific definitions and severity grading for both maternal and fetal AEs, enhancing safety assessments for drugs and interventions.

The framework was created through a comprehensive literature review and consensus from an international group of experts, resulting in 12 maternal and 19 fetal AE definitions that can be systematically applied in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. Spencer, RN., Hecher, K., Norman, G., et al.[2022]

In a South African pediatric intensive care unit (PICU), a retrospective audit identified a high rate of adverse events (50.8 per 100 patient days) among 80 patients, with catheter complications and hypoglycemia being the most common issues.

The study found that real-time registration during ward rounds reported a lower rate of adverse events (27.2 per 100 patient days) among 236 patients, highlighting that different registration methods can yield varying insights into patient safety and types of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. Vermeulen, JM., van Dijk, M., van der Starre, C., et al.[2014]

Continuous positive airway pressure (CPAP) is increasingly used for premature infants, and evidence suggests that short binasal prongs are the most effective method for delivering CPAP, especially during resuscitation in the delivery room.

There are ongoing debates about whether infants on CPAP should receive intubation and surfactant treatment beforehand, and further research is needed to establish optimal CPAP levels and compare outcomes between CPAP and endotracheal intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure: current controversies. Morley, C., Davis, P.[2019]

In a study of 151 premature infants with an average gestational age of 29.6 weeks, initiating continuous positive airway pressure (CPAP) immediately after birth significantly reduced the need for mechanical ventilation to 40%.

Only 13% of the infants required nasotracheal intubation, and the use of early CPAP was associated with a low incidence of pulmonary complications, supporting its role in decreasing neonatal morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early continuous positive pressure in the labor room]. Millet, V., Lacroze, V., Bartoli, JM., et al.[2019]

In a study of 259 infants born at 35 weeks gestational age, those who received continuous positive airway pressure (CPAP) in the delivery room had a significantly higher risk of being admitted to the NICU, with a 9.3 times greater risk compared to those who did not receive CPAP.

The use of delivery room CPAP was strongly associated with respiratory conditions such as respiratory distress syndrome (RDS) and transient tachypnea of the newborn (TTN), indicating that while CPAP is commonly used, it may lead to increased neonatal morbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What happens to 35 week infants that receive delivery room continuous positive airway pressure? Spillane, NT., Macalintal, F., Nyirenda, T., et al.[2021]

The study introduced a new voluntary and anonymous reporting system for near-miss and patient harm events in a pediatric intensive care unit, highlighting its importance for enhancing patient safety.

The effectiveness of the Patient Safety Report was demonstrated, showing it successfully captures incidents that could lead to patient harm, allowing for better assessment and prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an anonymous reporting system on near-miss and harmful medical error reporting in a pediatric intensive care unit. Grant, MJ., Larsen, GY.[2022]

Implementing an 'early CPAP' protocol in preterm infants (28-32 weeks gestation) significantly reduced the intubation rate from 89% to 73% and the use of exogenous surfactant from 86% to 67%, indicating improved respiratory management.

The early CPAP protocol also led to a decrease in the length of invasive mechanical ventilation and hospital stay, suggesting that this approach not only enhances patient outcomes but also reduces healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early CPAP protocol in preterm infants with gestational age between 28 and 32 weeks: experience of a public hospital. Vieira, BSPP., Souza, TR., Paschoal, LN., et al.[2021]

Prophylactic continuous positive airway pressure (CPAP) significantly reduced the rate of NICU admissions for respiratory distress in newborns delivered by elective cesarean section, with 134 infants receiving CPAP showing a lower admission rate compared to 125 infants receiving standard care (p=0.045).

While the incidence of transient tachypnea of the newborn (TTN) was lower in the CPAP group, the difference was not statistically significant (p=0.059), indicating that CPAP may be beneficial but further research is needed to confirm its effects on TTN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Prophylactic Continuous Positive Airway Pressure on Transient Tachypnea of the Newborn and Neonatal Intensive Care Admission in Newborns Delivered by Elective Cesarean Section. Celebi, MY., Alan, S., Kahvecioglu, D., et al.[2022]

In a study of 1560 preterm infants born at less than 32 weeks gestation, CPAP failure occurred in 10.3% of cases and was linked to significantly higher risks of mortality and serious complications like pneumothorax and pulmonary hemorrhage.

The risks associated with CPAP failure were found to be comparable to those seen in infants who initially received mechanical ventilation, indicating that CPAP failure poses serious health risks for vulnerable preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial respiratory support modality and outcome in preterm infants with less than 32 weeks of gestation in China: A multicentre retrospective cohort study. Wang, L., Li, JH., Yu, YH., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8521644/

Prophylactic or very early initiation of continuous positive ... When compared to mechanical ventilation, prophylactic nasal CPAP in very preterm infants reduces the incidence of BPD, the combined outcome of death and BPD, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05204719

Study Details | NCT05204719 | Prophylactic DR-CPAP on ... Patient characteristics, delivery room variables, and neonatal outcomes will be recorded in a secure password protected REDCap database. Official Title.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40993583/

Acceptability of immediate CPAP for preterm infants in the ... Initiating continuous positive airways pressure (CPAP) immediately after birth may reduce CPAP failure, the need for ventilation, and surfactant ...

4. pilotfeasibilitystudies.biomedcentral.com pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-024-01552-x

Impact of early continuous positive airway pressure in the ... We hypothesize that in such settings, early continuous positive airway pressure will reduce the rate of failure and therefore preterm mortality.

5. nature.com nature.com/articles/s41372-025-02420-z

Prophylactic surfactant therapy in the era of less invasive ... A meta-analysis showed that first-intention CPAP with selective surfactant administration reduced the risk of BPD or death compared with routine ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11451038/

Impact of early continuous positive airway pressure in the ... In HICs, the use of early CPAP, within 15 min of delivery, has been shown to decrease the need for mechanical ventilation by up to 45% and is ...

7. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202411-2169OC

Extended Continuous Positive Airway Pressure in Preterm ... Extending CPAP in stable preterm infants in the neonatal ICU may be a nonpharmacologic and safe therapy to promote lung growth and function.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9649384/

Continuous positive airway pressure for term and ≥34+0 ... Respiratory distress affects up to 7% of term (≥37+0 weeks' gestational age) newborn infants after birth, and 9% of late preterm (34+0–36+6 ...

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa072788

Nasal CPAP or Intubation at Birth for Very Preterm Infants In infants born at 25-to-28-weeks' gestation, early nasal CPAP did not significantly reduce the rate of death or bronchopulmonary dysplasia, as compared with ...