Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function

Premature Birth Clinical Trial

Official title:

Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04295564
• Other study ID #: eCPAP
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: January 10, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.

Description:

This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing. CPAP is a treatment widely used in the NICU in preterm infants right after they are born to help keep their lungs open/inflated. Although the benefit of CPAP after birth has been well studied, no one knows how long a stable preterm infant should stay on CPAP. The primary outcome of this study is to compare the lung volumes in the infants at 6 months of age by pulmonary function testing who were randomized to 2 extra weeks of CPAP in the NICU versus CPAP discontinuation, usual care. During the same pulmonary function test the investigators will also measure and compare how the infant's lungs diffuse gas.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: July 1, 2024
• Est. primary completion date: September 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 12 Weeks

Eligibility

Inclusion Criteria:

1. Infants born at >24 to = 32 weeks gestation

2. Treated with CPAP for = 24 hours for respiratory distress (either as initial therapy or following extubation)

Exclusion Criteria:

1. Significant congenital heart disease

2. Major malformations

3. Chromosomal anomalies

4. Culture proven sepsis at consent

5. Complex maternal medical conditions

6. Clinical instability

7. Multiple gestations > twins

8. <3rd or >97th percentile for weight85

9. Participating in another neonatal randomized clinical trial with a competing outcome

10. Mother/legal guardian without stable method of communication

Related Conditions & MeSH terms

• Neonatal
• Premature Birth
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• Additional 2 weeks of CPAP
Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.

Locations

Country	Name	City	State
United States	Doernbecher Neonatal Care Center at Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Cynthia McEvoy	Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lam R, Schilling D, Scottoline B, Platteau A, Niederhausen M, Lund KC, Schelonka RL, MacDonald KD, McEvoy CT. The Effect of Extended Continuous Positive Airway Pressure on Changes in Lung Volumes in Stable Premature Infants: A Randomized Controlled Trial. J Pediatr. 2020 Feb;217:66-72.e1. doi: 10.1016/j.jpeds.2019.07.074. Epub 2019 Sep 10. — View Citation

Praca ELL, Tiller CJ, Kisling JA, Tepper RS. An alternative method to measure the diffusing capacity of the lung for carbon monoxide in infants. Pediatr Pulmonol. 2018 Mar;53(3):332-336. doi: 10.1002/ppul.23926. Epub 2017 Dec 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory Morbidity	Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in lower respiratory morbidity through 12 months of age compared to infants who had CPAP discontinued, usual care	through 12 months of age (+/- 2 months)
Other	Bayley III Gross Motor Scores	Evaluate whether 2 extra weeks of CPAP in stable preterm infants results in improved neurodevelopmental outcomes (Bayley III Gross Motor Scores) through 12 months of age compared to infants who had CPAP discontinued, usual care	through 12 months of age (+/- 2 months)
Primary	Alveolar Volume	Establish that 2 additional weeks of CPAP in the NICU for stable preterm infants changes alveolar volume at approximately 6 months of age compared to infants who have CPAP discontinued, usual care.	4 - 8 months of age
Secondary	Lung Diffusion	Establish that 2 extra weeks of CPAP in stable preterm infants increases lung diffusion at approximately 6 months of age versus infants who have CPAP discontinued, usual care.	4 - 8 months of age
Secondary	Forced Expiratory Flows	Establish that 2 extra weeks of CPAP in stable preterm infants increases forced expiratory flows at approximately 6 months of age versus infants who have CPAP discontinued, usual care.	4 - 8 months of age