CPAP for Premature Birth

(PLANT Trial)

Recruiting at 5 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

120 Participants Needed

Trial Summary

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 data supports the idea that CPAP for Premature Birth is an effective treatment?

The available research shows that using CPAP in the delivery room for premature infants can reduce the need for more invasive procedures like intubation and mechanical ventilation. One study found that early use of CPAP in preterm infants improved outcomes compared to these more invasive methods. Another study indicated that CPAP could lower the risk of certain breathing problems and reduce the need for intensive care in newborns delivered by cesarean section. Overall, these findings suggest that CPAP is an effective treatment for helping premature babies breathe more easily right after birth. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Continuous Positive Airway Pressure (CPAP) for premature birth?

Research shows that using CPAP early in the delivery room can reduce the need for more invasive breathing support, like intubation, in premature infants. It also helps improve breathing outcomes in newborns delivered by cesarean section and those born at or after 34 weeks of pregnancy. ^{1 2 3 4 5}

What safety data exists for CPAP in premature birth treatment?

The provided research does not directly address safety data for CPAP in premature birth treatment. However, it highlights the importance of adverse event reporting and monitoring in healthcare settings, which is crucial for assessing the safety of any medical intervention, including CPAP. The studies emphasize the need for effective reporting systems and standard definitions for adverse events to improve patient safety, which can be applied to CPAP treatments as well. ^{6 7 8 9 10}

Is CPAP generally safe for use in humans?

The research articles provided do not contain specific safety data about CPAP (Continuous Positive Airway Pressure) for premature birth or other conditions. ^{6 7 8 9 10}

Is Continuous Positive Airway Pressure a promising treatment for premature birth?

Yes, Continuous Positive Airway Pressure (CPAP) is a promising treatment for premature birth. It can reduce the need for more invasive procedures like intubation and mechanical ventilation in premature infants. CPAP is increasingly used for initial respiratory support in preterm infants, especially those born before 32 weeks of gestation. ^{1 2 3 11 12}

How is the treatment CPAP for premature birth different from other treatments?

CPAP (Continuous Positive Airway Pressure) is unique because it provides gentle, continuous air pressure to keep a premature baby's airways open right from the delivery room, potentially reducing the need for more invasive procedures like intubation and mechanical ventilation. ^{1 2 3 11 12}

What is the purpose of this trial?

A Pragmatic Randomized Controlled Pilot Trial to Evaluate the Impact of Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen in Spontaneously Breathing Late Preterm Newborn Infants Born by Cesarean Delivery, Compared to No Early Prophylactic Continuous Positive Airway Pressure with or without Supplemental Oxygen, on the Need for Further Respiratory Support Leading to NICU Admissions.

Research Team

Birju Shah, MD

Principal Investigator

Univeristy of Oklahoma Health Sciences Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

What happens to 35 week infants that receive delivery room continuous positive airway pressure? [2021]

2. France pubmed.ncbi.nlm.nih.gov

[Early continuous positive pressure in the labor room]. [2019]

3. United States 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. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Early CPAP protocol in preterm infants with gestational age between 28 and 32 weeks: experience of a public hospital. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure for term and &#8805;34+0 weeks' gestation newborns at birth: A systematic review. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse events during nursing care procedure in intensive care unit: The PREVENIR study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure: current controversies. [2019]

12. England 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. [2022]