Does the Length of Surfactant Treatment Affect How Well Very Premature Babies Stabilize? – Comparing 1-Minute and 5-Minute Methods

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

24 Feb 2026 → ongoing

Decision date (initial)

2025-12-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Objective of this clinical trial is to assess differences in SpO2, HR and crSO2, in accordance to the group randomisation of the duration of surfactant administration (“1min” vs. “5 min”) during the LISA procedure in preterm neonates < 28 weeks of gestational age during the first 72 hours after birth.

Secondary objectives 6

1. differences in monitoring parameters (SpO2, HR, crSO2, MABP) up to three hours after the LISA procedure according to the randomisation group (“1min” vs. “5 min”).
2. differences in need of supplemental oxygen, the amount of bradycardia and hypoxia (in minutes) up to three hours after surfactant administration according to the randomisation group (“1min” vs. “5 min”).
3. differences in vital parameters until three hours after extubation, assessed every five minutes, according to the randomisation group (“1min” vs. “5 min”).
4. differences in need for a second (repetitive) dose of surfactant during the first two days after surfactant administration according to the randomisation group (“1min” vs. “5 min”).
5. differences in need for invasive ventilation during the first two days after surfactant administration according to the randomisation group (“1min” vs. “5 min”).
6. the influence of duration of surfactant administration (“1min” vs. “5 min”) on short-term outcome (BPD, IVH, PVH, PVL) until discharge or term age, whatever will come first.

Conditions and MedDRA coding

Neonatal respiratory distress syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Preterm neonate <28+0 weeks (gestational age up to 27 weeks and 6 days)
2. Indication of surfactant administration via the LISA method
3. Postnatal age < 72 hours

Exclusion criteria 3

1. Invasive ventilation, indication of INSURE procedure
2. Severe pulmonary or cardial malformation affecting oxygenation or congenital cerebral malformation
3. Preexisiting diagnose of any IVH > grade 2 or PVH.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Vital parameters (SpO2, HR and crSO2) during surfactant administration; defined as maximum changes/drop from baseline starting with the beginning of the surfactant administration after insertion of the thin catheter till 15 minutes after the LISA procedure.

Secondary endpoints 6

1. SpO2, HR, crSO2 and MABP up to three hours after surfactant administration; defined as maximum changes/drop from baseline starting with the beginning of the surfactant administration after insertion of the thin catheter till three hours after LISA procedure.
2. Need of supplemental oxygen, the amount of bradycardia and hypoxia (in minutes); up to three hours after surfactant administration.
3. Vital parameters until three hours after extubation, assessed every five minutes.
4. Need for a second/repetitive dose of surfactant
5. Invasive ventilation during the first two days after initial surfactant administration.
6. short-term outcome (morbidity) until discharge or term age dependent on what comes first.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Coordination Center for Clinical Studies

Public contact point

Organisation

Medical University Of Graz

Contact name

Coordination Center for Clinical Studies

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications