Clinical trial NCT04295564: Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function
Official title: Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Neonatal
Premature Birth
Respiratory Distress Syndrome
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Indiana University
First posted: 2020-03-04
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Alveolar Volume
timeFrame: 4 - 8 months of age
Secondary outcomes:
measure: Lung Diffusion
timeFrame: 4 - 8 months of age
measure: Forced Expiratory Flows
timeFrame: 4 - 8 months of age
Other outcomes:
measure: Respiratory Morbidity
timeFrame: through 12 months of age (+/- 2 months)
measure: Bayley III Gross Motor Scores
timeFrame: through 12 months of age (+/- 2 months)
Locations:
city: Portland
country: United States
facility: Doernbecher Neonatal Care Center at Oregon Health & Science University
state: Oregon
Study officials:
References:
citation: 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.
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.