NCT05796128

Brief Summary

The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants. The main question it aims to answer is: • Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 \>0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

March 8, 2023

Last Update Submit

March 21, 2023

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

SurfactantLISA procedurePreterm infant

Outcome Measures

Primary Outcomes (1)

  • Surfactant or mechanical ventilation

    Need for a second dose of surfactant or mechanical ventilation

    The need for a second dose of surfactant or mechanical ventilation will be evaluated within the first 72 hour of life

Secondary Outcomes (3)

  • Noninvasive ventilation

    Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

  • Mechanical ventilation

    Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

  • Bronchopulmonary dysplasia

    Participants will be monitored for the duration of their hospital stay, which is an average of 10 weeks

Study Arms (2)

LISA with NCPAP

ACTIVE COMPARATOR

In this group, infants will receive NCPAP during LISA procedure.

Procedure: Nasal continuous positive airway pressure (NCPAP)

LISA with NIPPV

EXPERIMENTAL

In this group, infants will receive NIPPV during LISA procedure.

Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)

Interventions

Nasal Intermittent Positive Pressure Ventilation (NIPPV)PROCEDURE

In this group, infants will receive NIPPV during LISA procedure.

LISA with NIPPV
Nasal continuous positive airway pressure (NCPAP)PROCEDURE

In this group, infants will receive NCPAP during LISA procedure.

LISA with NCPAP

Eligibility Criteria

Age0 Hours - 72 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants with gestational age between 25+0 and 31+6 gestational weeks,
  • RDS which does not require MV
  • Treatment with NCPAP and FiO2 \>0.30 within the first 6 hours of life,
  • First dose of caffeine administered

You may not qualify if:

  • absence of informed consent,
  • major congenital malformations,
  • hydrops fetalis,
  • chromosomal diseases,
  • previous treatment with surfactant,
  • cardiorespiratory instability requiring treatment with vasoactive drugs,
  • pneumothorax,
  • death within 72 hours of life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Careggi University Hospital, Division of Neonatology

Florence, 50141, Italy

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornPremature Birth

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiratory Distress SyndromeLung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Pediatrics

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 3, 2023

Study Start

October 1, 2020

Primary Completion

October 31, 2022

Study Completion

January 23, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

IT(1)