TerminatedNot Applicable

NIV-MISA-NRDS Trial: a Multicenter Study in China

Stopped: The trial was terminated early based on interim analysis results indicating futility. The decision was approved by the Data Safety Monitoring Committee (DSMC).

China312 participantsStarted 2021-12-01

Plain-language summary

BACKGROUND Non-invasive ventilation (NIV) treatment have been developed to minimize lung damage and to avoid invasive mechanical ventilation (IMV) in preterm infants, especially in those with gestational age less than 30 weeks. Our hypothesis is that for preterm infants less than 30 weeks with potential to develop neonatal respiratory distress syndrome (NRDS), nasal continuous positive airway pressure (NCPAP) is non-inferior to the nasal intermittent positive pressure ventilation (NIPPV) as primary respiratory support before minimal invasive surfactant administration (MISA). DESIGN, SETTING, AND PARTICIPANTS The NIV-MISA-NRDS trial is planned as an unblinded, multicenter, randomized, non-inferiority trial at 11 tertiary care neonatal intensive care units in China. Eligible infants are preterm infants of 24 to 29+6 weeks' gestational age who have spontaneous breaths at birth and require primary NIV support for NRDS in the first 2 h of life. Infants are randomized 1:1 to treatment with either NCPAP or NIPPV once admitted into neonatal intensive care unit (NICU). If the patient with progressively aggravates respiratory distress and clinically diagnose as NRDS, pulmonary surfactant will be supplemented by minimal invasive surfactant administration (MISA) in the first 2 hours . MAIN OUTCOMES AND MEASURES The primary outcome is NIV treatment failure within 72 hours after birth, as determined by objective oxygenation, blood gas, and apnea criteria, or the need for intubation and mechanical ventilation. Secondary outcomes mainly include the incidence of complications during hospitalization . With a specified noninferiority margin of 10%, using a two-sided 95% CI and 80% power, the study requires 480 infants per group (total 960 infants in the study).

Who can participate

Age range30 Minutes – 4 Months

SexALL

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Inclusion criteria

✓. Infants of 24 to 29+6 weeks GA.
✓. Infants with spontaneous breathing and signs of respiratory distress will receive non-invasive respiratory support (PEEP of 6 cmH2O and fraction of inspired oxygen\[FiO2\]≤0.40) immediately after birth in the delivery room and during transfer to NICU. Once the infant is settled down in the incubator, and the ventilation support of NCPAP or NIPPV by ventilator in NICU will by started according to the randomization of protocol.
✓. Under NCPAP or NIPPV, the surfactant will be administered via MISA approach within 120 minutes after birth if the infant required FiO2\>0.3 for transcutaneous oxygen saturation \[SpO2\]\>85%, or Silverman Anderson Score \[SAS\] \>5 points or SAS increasing \>2 points per hour.
✓. Parental consent will be obtained for all participants.

Exclusion criteria

✕. Infants who have been intubated prior to pulmonary surfactant administration due to postnatal resuscitation or other reasons.
✕. Infants with obvious malformations affecting respiratory function.
✕. Infants who have been transferred out to other hospitals for surgery or died for other complications with uncompleted data.

What they're measuring

NIV treatment failure within the first 72 hours of life

Timeframe: From enrollment to the first 72 hours of life

Trial details

NCT IDNCT05137340

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-01

View on ClinicalTrials.gov More Minimal Invasive Surfactant Administration in Two Different Non-invasive Ventilation Modes to NRDS Infants trials