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Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM

NCT06123845 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-01-23

No results posted yet for this study

Summary

The aim of this randomized pilot clinical trial of preterm infants requiring noninvasive respiratory support for respiratory distress syndrome (RDS) at birth is to improve short-term respiratory outcomes. The main question it aims to answer is:

* Can a CPAP (or a PEEP if ventilation is needed) administered with a face mask and a T-piece at a level of 8 cmH2O improve lung recruitment in the delivery room when compared to administration of a level of 5 cmH2O in a control group?
* Secondly, can improved lung recruitment in the first few minutes of life provide long-term benefits to the premature infant? The participants will be premature infants between 26 and 29+6 weeks gestational age.

Conditions

  • Respiratory Distress Syndrome in Premature Infant

Interventions

BEHAVIORAL

static CPAP 8 cmH2O

Set static CPAP or PEEP pressure level at 8 cmH2O

BEHAVIORAL

static CPAP 5 cmH2O

Set static CPAP or PEEP pressure level at 5 cmH2O

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-11
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06123845 on ClinicalTrials.gov