N/A
Completed N=460
Sustained Aeration of Infant Lungs Trial
Source: ClinicalTrials.gov NCT02139800 ↗Enrolled (actual)
460
Serious AEs
22.5%
Results posted
Jun 2020
Primary outcomePrimary: Combined Outcome of Death or Bronchopulmonary Dysplasia — 125; 137 Participants
Summary
This study is a 2-arm randomized, controlled, multi-center clinical trial to determine which of two strategies at birth are best to optimally aerate the lung of preterm infants. Specifically we will determine in 600 infants of 23-26 weeks gestational age (GA) requiring respiratory support at birth which of two lung opening strategies - either a standard PEEP/CPAP of 5-7 cm H2O in the delivery room (DR), as compared to early lung recruitment using Sustained Inflation (SI) in the DR, will result in a lower rate of the combined endpoint of death or bronchopulmonary dysplasia (BPD) at 36 weeks gestational age.
Hypotheses:
1. Early lung recruitment with SI superimposed upon standard PEEP/CPAP in the DR will reduce the need for mechanical ventilation in the first seven days of life, and reduce need for surfactant use; and
2. A policy of DR SI on standard PEEP/CPAP recruitment will confer better outcomes at 36 weeks post-menstrual age (PMA) than standard PEEP/CPAP
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Outcome of Death or Bronchopulmonary Dysplasia |
125; 137 | — |
| SECONDARY Oxygen Profile Over First 24 Hours |
— | — |
| SECONDARY Oxygen Profile With Highest FiO2 Level up to 48 Hours |
— | — |
| SECONDARY Heart Rate in the Delivery Room (DR) |
— | — |
| SECONDARY Detailed Status on Departure From the Delivery Room (DR) |
— | — |
| SECONDARY Use of Inotropes on Arrival in NICU |
— | — |
| SECONDARY Need for Intubation in Delivery Room |
— | — |
| SECONDARY Pressure-volume Characteristics in the Delivery Room (DR) |
— | — |
| SECONDARY Pneumothorax or New Chest Drains in the First 48 Hours of Life |
— | — |
| SECONDARY Duration of Any Chest Drain In-situ Post-DR |
— | — |
| SECONDARY Intraventricular Hemorrhage by All Grades |
— | — |
| SECONDARY Chest X-ray Between Days 7-10 |
— | — |
| SECONDARY Death or Need for Positive Pressure Ventilation |
— | — |
| SECONDARY Highest FiO2 and Area Under the FiO2 Curve for the First Week of Life |
— | — |
| SECONDARY Pneumothorax and Pulmonary Interstitial Emphysema (PIE) |
— | — |
| SECONDARY Survival to Discharge Home Without BPD, Retinopathy of Prematurity (Grades 3 & 4), or Significant Brain Abnormalities on Head Ultrasound |
— | — |
| SECONDARY Duration of Respiratory Support (Ventilation, CPAP, Supplemental Oxygen) |
— | — |
| SECONDARY Death in Hospital |
— | — |
| SECONDARY Retinopathy of Prematurity (ROP) Stage 3 or Greater Requiring Treatment |
— | — |
| SECONDARY Use of Postnatal Steroids for Treatment of BPD |
— | — |
| SECONDARY Length of Hospital Stay |
— | — |
| SECONDARY Neurodevelopmental and Respiratory Outcome at 22-26 Months Corrected Gestational Age |
— | — |
Eligibility Criteria
Inclusion Criteria
- Gestational age (GA) at least 23 weeks but less than 27 completed weeks by best obstetrical estimate
- Requiring resuscitation/respiratory intervention at birth -"apneic, labored breathing, gasping" (as defined in NRP 2011 AAP 6th Edition p.45)
Exclusion Criteria
- Considered non-viable by the attending neonatologist
- Refusal of antenatal informed consent
- Known major anomalies, pulmonary hypoplasia
- Mothers who are unable to consent for their medical care and who do not have a surrogate guardian will not be approached for consent
Data sourced from ClinicalTrials.gov (NCT02139800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.