N/A
Completed N=31
Inhaled Nitric Oxide (iNO) as an Adjunct to Neonatal Resuscitation
Respiratory Distress Syndrome in Premature Infants · Very Low Birth Weight Baby
Source: ClinicalTrials.gov NCT01220687 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Maximum Factional Inspired Oxygen Percent (FiO2) — 48; 39 percentage of Inspired Oxygen — p=0.0012
Summary
This study hopes to determine whether nitric oxide along with oxygen during the first 20 minutes of life in infants needing help with breathing will reduce the percentage and total exposure to oxygen during that time frame. Although the use of oxygen in management of breathing is an important part of supporting baby immediately after delivery, there is more evidence that too much exposure to oxygen may lead to potential problems for your baby later. Oxygen exposure can be harmful to premature babies developing lungs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Factional Inspired Oxygen Percent (FiO2) |
48; 39 | 0.0012 sig |
| PRIMARY Rate of Hyperoxia |
708; 370 | <0.0001 sig |
| PRIMARY Pre and Postductal Saturation Levels |
90.5; 82.8; 79.9; 78.2 | — |
| PRIMARY Heart Rate During Resuscitation |
139; 130; 161; 149; 168; 158 | — |
| PRIMARY Need for Intubation |
4; 4 | — |
| SECONDARY Intraventricular Hemorrhage > Grade 2 |
2; 0 | — |
| SECONDARY Infants With Patent Ductus Arteriosus (PDA) Requiring Treatment |
4; 1 | — |
| SECONDARY Retinopathy of Prematurity (ROP)> Stage 2 |
4; 1 | — |
| SECONDARY Mechanical Ventilation, Non-invasive Ventilation (NIV), and Length of Stay in Days (LOS) |
14; 8.5; 15; 20.5; 52; 70.5 | — |
| SECONDARY Bronchopulmonary Dysplasia |
5; 5 | — |
| SECONDARY Late Onset Sepsis |
2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Infants that are 25 0/7 - 31 6/7 weeks gestation
- Infants who require Continuous Positive Airway Pressure (CPAP) or Positive Pressure Ventilation ( PPV) during delivery room resuscitation.
Exclusion Criteria
- Refusal of consent
- Known complex congenital anomalies of the heart or lungs
- Known major genetic defects
- Hydrops fetalis
Data sourced from ClinicalTrials.gov (NCT01220687). 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.