Transition Without CPAP for Shortness of Breath in Newborns
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether newborns with mild breathing problems can safely go without CPAP, a machine that helps keep airways open. Researchers aim to determine if these babies can transition smoothly without it and are examining the frequency of pneumothorax, a lung issue where air leaks into the space between the lung and chest wall. Full-term babies born through planned C-sections who show mild breathing trouble, such as nasal flaring or occasional grunting, might be suitable candidates. The trial compares two groups: one receives CPAP immediately, while the other is observed briefly to assess the need for CPAP. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in newborns, offering a unique opportunity to contribute to pioneering medical knowledge.
What prior data suggests that transitioning without CPAP is safe for newborns with mild respiratory distress?
Research on helping newborns transition without continuous positive airway pressure (CPAP) remains in its early stages. This study is the first to test this specific method. In early-stage medical research, safety information is just beginning to be gathered. Detailed data on newborns' responses to this treatment is not yet available, but the process involves closely monitoring the babies for 20 minutes. If their breathing does not improve, CPAP is provided as needed.
Since this trial is in the early phase, the main focus is on safety. Researchers are carefully monitoring for any side effects or problems. If the treatment appears unsafe, they will make quick changes.
Currently, solid data on how well newborns handle this approach is lacking. Prospective participants should know that researchers are committed to ensuring the safety of the newborns involved.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it examines a method called "watchful waiting" for managing mild respiratory distress in newborns. Unlike the standard approach, which involves immediate use of Continuous Positive Airway Pressure (CPAP), this method involves observing the newborn for 20 minutes before deciding on CPAP. This approach could potentially reduce unnecessary interventions and related stress for both newborns and parents, offering a more personalized way to address mild cases.
What evidence suggests that transitioning without CPAP is effective for shortness of breath in newborns?
This trial will compare two approaches for newborns with mild respiratory distress. One group will undergo "watchful waiting," where neonates are observed for 20 minutes and receive CPAP if necessary. The other group will receive the standard of care with immediate CPAP. Research suggests that newborns with mild breathing problems might safely adjust without CPAP, a machine that helps keep their airways open. Studies on similar methods, such as NIPPV, which provides gentle breathing support through the nose, have shown promise in reducing breathing issues more effectively than CPAP. Although specific data for full-term babies is limited, the success seen in premature babies suggests that less invasive support might be effective. This approach could reduce the risk of complications like a collapsed lung. However, more research is needed to confirm these benefits for full-term newborns.14678
Who Is on the Research Team?
Nicole Spillane, MD
Principal Investigator
Hackensack Meridian Health
Are You a Good Fit for This Trial?
This trial is for full-term infants born via scheduled C-section who show signs of mild breathing difficulty, like nasal flaring or fast breathing. Infants with meconium in the amniotic fluid, more severe respiratory issues, those needing resuscitation at birth, or with major birth defects can't participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs
Initial Hospital Stay
Neonates are monitored for respiratory distress and potential NICU admission during the initial hospital stay
Follow-up
Participants are monitored for safety and effectiveness after initial treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transition without Continuous Positive Airway Pressure (CPAP)
Trial Overview
The study aims to see if newborns with mild respiratory distress can safely transition without using CPAP (a device that keeps airways open). It also looks at how often a lung complication called pneumothorax happens in these babies.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Neonates with mild respiratory distress are observed for 20 minutes, and CPAP is administered at 25 minutes of life if respiratory distress continues or earlier if moderate to severe respiratory distress occurs
Continuous positive airway pressure (CPAP) is administered for mild respiratory distress
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hackensack Meridian Health
Lead Sponsor
Citations
Respiratory Transition Without Continuous Positive Airway ...
The primary aim of this research project is to determine if term neonates (37:0 to 41:6 weeks' gestational age) with mild respiratory distress ...
The Outcomes of Preterm Infants with Neonatal Respiratory ...
This study aims to compare the outcomes between MIST administered with nasal continuous positive airway pressure (NCPAP) versus nasal intermittent positive ...
NIPPV vs CPAP: Lessons from meta-analyses
Overall, all meta-analyses concluded that NIPPV was likely superior to CPAP in preventing respiratory failure,38, 39, 40 (Fig. 1). We reported a relative risk ( ...
Respiratory Management of the Preterm Infant: Supporting ...
Studies on preterm infants indicate that when compared with CPAP, sNIPPV reduces the work of breathing, reduces thoracoabdominal asynchrony, increases tidal ...
Extended Continuous Positive Airway Pressure in Preterm ...
This study demonstrates that extending the duration of nasal bubble CPAP in stable preterm infants can stimulate both their lung and blood ...
Bubble CPAP therapy for neonatal respiratory distress in level ...
The therapy success rate was 93.7%; only nine infants failed bCPAP. The most common side effect was physical facial injury. Conclusion. The use ...
With or Without Nasal Continuous Positive Airway Pressure ...
Our study showed that delayed cord clamping with nCPAP was feasible and safe in preterm infants with gestational age <32 weeks.
The Outcomes of Preterm Infants with Neonatal Respiratory ...
This study aims to compare the outcomes between MIST administered with nasal continuous positive airway pressure (NCPAP) versus nasal intermittent positive ...
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