Efficacy of nasal high frequency oscillation ventilation (NHFOV) compared to noninvasive positive-pressure ventilation (NIPPV) in pre-terms with respiratory distress syndrome during the first 7 days of life

Not Applicable

Completed

• Conditions: Respiratory Distress Syndrome; Premature neonates; Low birth weight; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12622000291785
• Lead Sponsor: PNS Shifa Hospital

Brief Summary

48 neonates with respiratory distress syndrome were divided in to two group 24 each in NHFOV and NIPPV. The mean birth wt was significant in intervention (NHFOV)vs Control (NIPPV) group 1347±458 gms vs 1672±534 , no change in the other general characteristics of neonates in two groups . In intervention (NHFOV) group 11(64.7%) and control(NIPPV) group 6(35.3%) preterm babies required invasive mechanical ventilation during first 7 days, whereas days of supplementary oxygen in intervention( NHFOV) was 10(35.7%) vs 18(64.3%)in control(NIPPV) group which was significant.Four patients were intubated for pulmonary hemorrhage(NHFOV ,n=4).The reason for respiratory failure were hypoxia, bradycardia and respiratory acidosis (NHFOV ,n= 8 ; NIPPV ,n= 6 ). No difference in Secondary outcomes among intervention (NHFOV) and control (NIPPV) group.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-08-27
• Study Start: 2022-02-16
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Neonates with these following criteria fulfilled was included in the study.
1.Gestational age 27 week and 34week (estimated on postmenstrual date and early gestational ultasonographic findings).
Neonates with respiratory distress syndrome ( RDS) will be based on clinical manifestations ( tachypnea ,nasal flaring, and or grunting) or respiratory distress syndrome (RDS) Silverman score >5.
2. Moderate –severe respiratory distress syndrome ( RDS) is based on arterial to alveolar PO2 (a/A PO2) ratio and Silverman score within the first hour of life (a/A PO2 ratio . 0.30 or Silverman score >6)

Exclusion Criteria

1.Any baby intubated for resuscitation or for other reasons.
2.birth weight less than 600gm,
3.Major congenital malformations such as cystic adenomatous malformations, sequestration, diaphragmatic hernia) or pulmonary hypoplasia , or known complex congenital heart disease.
4.Pulmonary hemorrhage.
5.Grade 4 intraventricular hemorrhage.
6.Cardiopulmonary arrest needing prolonged resuscitation.
7.Transferred out of the NICU before randomization.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Requirement for invasive mechanical ventilation during first 7 days of life in neonate with respiratory distress syndrome randomized in intervention and control groups. <br>Requirement for invasive mechanical ventilation was accessed by following composite outcome,<br>severe respiratory acidosis (PaCO2 > 65 mmHg with pH < 7.20),<br> severe apnea and bradycardia <br>hypoxemia (FiO2 > 0.5 with PaO2 < 50 mmHg from an arterial blood gas sample),<br> severe respiratory distress<br>pulmonary hemorrhage, and cardiopulmonary arrest needing chest compressions.<br> Respiratory acidosis was accessed by arterial ABGs ,<br>Apnea and bradycardia was accessed on clinical examination and by oxygen and heart rate monitor.<br>Sever respiratory distress,pul heamorrhage and cardiopulmonary arrest was accessed by clinical examination.[first 7 days of life after birth.]