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

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 - SurPluS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021504

Enrollment

186

Registered

2020-08-18

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P23.9 P25.1 P26.8 P28.5 P27.1 P52.0 P52.1 P52.2 P52.4 P36.9 P39.9 P77 P78.0 P91.1 H35.1

Interventions

Group 1: Premterm babies below 32nd weeks of gestations with premature rupture of the membranes (>5 days) and intratracheal administration of surfactant and budenosid on the first day of life Group 2:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: lethal malformations

Design outcomes

Primary

Measure	Time frame
1. Mortality or treatment with systemic steroids due to bronchopulmonary dysplasia.	—

Secondary

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

Measure

Time frame

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

—

Countries

Austria, Germany

Contacts

Public ContactGuido Stichtenoth

Klinik für Kinder- und Jugendmedizin

Guido.Stichtenoth@uksh.de+4945150042822

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026