Phase 3
Completed N=124
NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)
RDS of Prematurity
Source: ClinicalTrials.gov NCT02259400 ↗
Enrolled (actual)
124
Serious AEs
6.5%
Results posted
Jan 2015
Primary outcomePrimary: Duration of NIV Support — 89; 87 HOURS — p=< 0.05
Summary
The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of NIV Support |
89; 87 | < 0.05 sig |
| PRIMARY Failure of NIV Support |
10; 8 | — |
| SECONDARY Death |
0; 2 | — |
| SECONDARY Bronchopulmonary Dysplasia (BPD) |
7; 7 | — |
| SECONDARY Pneumothorax (PNX) |
2; 4 | — |
| SECONDARY Intraventricular Hemorrhage (IVH) |
2; 2 | — |
| SECONDARY Periventricular Leukomalacia (PVL) |
2; 4 | — |
| SECONDARY Retinopathy of Prematurity (ROP) |
2; 3 | — |
| SECONDARY Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA) |
18; 14 | — |
| SECONDARY Necrotizing Enterocolitis (NEC) |
0; 2 | — |
| SECONDARY Newborns Who Received Multiple Surfactant Doses |
21; 18 | — |
| SECONDARY Early Onset Sepsis |
13; 15 | — |
| SECONDARY Late Onset Sepsis |
21; 14 | — |
Eligibility Criteria
Inclusion Criteria
- All inborn VLBW infants (birthweight less than 1500 g and Gestational Age < 32 wks) with signs of RDS, spontaneously breathing and only supported by N-CPAP, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies.
Exclusion Criteria
- Apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth
- Newborns with genetic disease and/or with major congenital malformations
- Newborns for whom it was not obtained informed consent within two hours from birth
Data sourced from ClinicalTrials.gov (NCT02259400). 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.