Aerosolized surfactant in the first hour of life

Phase 2

• Conditions: Infant Respiratory Distress Syndrome; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12610000857000
• Lead Sponsor: School of Women’s and Infants’ Health (SWIH)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Preterm infants with a gestational age (GA) between 29 w 0 d and 33 w 6 d AND
late preterm and term infants with a GA between 34 w 0 d and 39 w 6 d
with clinical or radiological signs of RDS requiring FiO2 of 0.22- 0.30 to maintain a peripheral haemoxyglobin saturation of 88-94%.

Exclusion Criteria

cardiorespiratory instability, cardiothoracic malformations, obvious chromosomal aberrations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation assessed in minutes from prospective documentation. <br><br>Extubation criteria:babies will be extubated at the discretion of the attending consultant with regard to oxygen requirement and clinical condition[Duration of mechanical ventilation at the end of the 1st 72 h of life.];Need for intubation.<br>Criteria for intubation will include one or more of the following: <br>a) FiO2 > 0.35 over more than 30 minutes OR <br>b) FiO2 > 0.45 at anytime, OR <br>c) more than 4 apnoeas per hour OR <br>d) two apnoeas requiring bag and mask ventilation, OR <br>e) two capillary blood gas samples with a pH < 7.2 and pCO2 > 65 mmHg (or 60 mm Hg if arterial blood gas sample)<br>f) clinical deterioration necessitating intubation as judged by the treating clinician[Need for intubation in first 72 h of life]

Secondary Outcome Measures

Name	Time	Method
Safety of the nebulisation procedure will be assessed by recording of apnea events and need for nasal suction occurring during the nebulisation period and comparing those to the background rate of apnea in the control group.<br>We will also record any significant clinical event during nebulisation requiring medical intervention.<br><br>Safety of the procedure will be further assessed by development of airleak syndromes, and frequency of apnea and/or bradycardia in the first 72 hours[Assessments will be made over the period of nebulisation, and again at 72 hours.];Physiological stability as determined by respiratory rate, pulse rate, mean blood pressure, FiO2, and blood pH[72 h];Number of surfactant treatments administered[72 h];Duration of mechanical ventilation[14 d];Any airleak syndrome[72 h]