NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS)
Preterm Infants
Bottom Line
View on ClinicalTrials.gov: NCT03099694 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- noninvasive high-frequency ventilation (nHFOV) (Procedure); nasal continuous positive airway pressure (nCPAP) (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Xingwang Zhu
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Required Intubation |
26; 15 | — |
| SECONDARY the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ) |
2; 4 | — |
| SECONDARY the Incidence of Pneumothorax |
1; 3 | — |
| SECONDARY the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II) |
7; 11 | — |
| SECONDARY the Incidence of Retinopathy of Prematurity (>Stage II) |
9; 7 | — |
| SECONDARY The Score of Bayley Scales of Infant Development |
— | — |
| SECONDARY the Incidence of Bronchopulmonary Dysplasia(BPD) |
15; 17 | — |
| SECONDARY the Incidence of Abdominal Distention |
19; 26 | — |
| SECONDARY The Time of Non-invasive Ventilation |
81.0; 78.5 | — |
| SECONDARY Length of Hospitalization |
29.0; 31.0 | — |
| SECONDARY Predischarge Mortality |
4; 6 | — |
| SECONDARY Length of O2 Therapy |
7.0; 8.0 | — |
| SECONDARY Number of Participants With Thick Secretions Causing an Airway Obstruction |
8; 21 | — |
Summary
Eligibility Criteria
Inclusion criteria
(1)Gestational age (GA) is from 26 to 34 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings; (3) RDS Silverman score>5; (4) informed parental consent has been obtained.
Exclusion criteria
(1) severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7; (2)major congenital malformations or complex congenital heart disease; (3) group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; (4) cardiopulmonary arrest needing prolonged resuscitation; (5) transferred out of the NICUs without treatment.
Data sourced from ClinicalTrials.gov (NCT03099694). 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.