Early intratracheal treatment with surfactant plus steroids (SurPluS) in low birth-weight premature infants following preterm premature rupture of the membranes-clincal course and outcome

Recruiting

• Conditions: P23.9; P25.1; P26.8; P28.5; P27.1; P52.0; P52.1; P52.2; P52.4; P36.9

• Registration Number: DRKS00021504
• Lead Sponsor: niversität zu Lübeck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

1.) Premature rupture of the membrans (>5 days)
2.) Oligohydramnios or anhydrmnios
3.) Severe respiratory distress syndrome in need of treatment with
a) surfatctant (controls)
b) surfactant and budenoside

Exclusion Criteria

lethal malformations

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mortality or treatment with systemic steroids due to bronchopulmonary dysplasia.

Secondary Outcome Measures

Name	Time	Method
1.) Bronchopulmonary Dysplasia without treatment with systemic steroids <br>2.) Retinopathy of prematurity<br>3.) Intraventricular haemorrhage<br>4.) Periventricular leukomalacia<br>5.) length of non-invasive and invasive ventilations<br>6.) length of oxygen supplementation<br>7.) Pneumothorax<br>8.) need of treatment with oral diuretika oder pulmonary hypertensive medication at time of discharge <br>6.) Development of a sepsis<br>7.) development of SIRS<br>8.) failure to thrive