Neonatal Interventional Nebulized Surfactant for Preterm Infants with RDS (Neo-INSPIRe)

A South African, multicenter, phase 2, non-blinded, randomized controlled trial to determine if aerosolized surfactant plus continuous positive airway pressure (CPAP) compared to CPAP alone can improve the course of infants with respiratory distress syndrome (RDS) by decreasing their need for intratracheal bolus surfactant in the first 72 hours of age

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202307490670785

Enrollment

232

Registered

2023-07-18

Start date

2023-05-14

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Respiratory Paediatrics

Interventions

Aerofact

CPAP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inborn ? Birth Weight of 900 - 1999 g ? 27 – 34 weeks gestational age ? 2 - 24 hours of age at time of randomization ? Persistent fractional inspired oxygen (FiO2) of 0.25 – 0.35 on nCPAP at 5-7 cmH2O to maintain peripheral oxygen saturation of 90 -95%. FiO2 requirement needs to be sustained for at least 15 minutes.

Exclusion criteria

Exclusion criteria: Administration of inotropes and/or intubation prior to enrolment (in the delivery room or NICU) ? 5-minute Apgar score = 5 ? Prior instillation of intratracheal bolus surfactant ? Pneumothorax that requires needle thoracentesis or insertion of an intercostal chest drain ? Life-threatening congenital anomaly ? Known or suspected chromosomal abnormality ? Known or suspected congenital infection including syphilis, cytomegalovirus or toxoplasmosis.

Design outcomes

Primary

Measure	Time frame
Proportion of infants requiring intratracheal bolus surfactant administration in the first 72 hours of age in each study group	—

Secondary

Measure	Time frame
Incidence of BPD or death at 36 weeks postmenstrual age between groups;Proportion of infants meeting failure criteria in the first 72 hours of age in each group;Number of hours on mechanical ventilation during hospital stay between groups;Number of days on CPAP and/or HFNC, and supplementary oxygen during hospital stay between groups;Incidence of adverse events and usually reported selected comorbidities of prematurity;Incidence of BPD in survivors at 36 weeks postmenstrual age between groups	—

Measure

Time frame

Incidence of BPD or death at 36 weeks postmenstrual age between groups;Proportion of infants meeting failure criteria in the first 72 hours of age in each group;Number of hours on mechanical ventilation during hospital stay between groups;Number of days on CPAP and/or HFNC, and supplementary oxygen during hospital stay between groups;Incidence of adverse events and usually reported selected comorbidities of prematurity;Incidence of BPD in survivors at 36 weeks postmenstrual age between groups

—

Countries

South Africa

Contacts

Public ContactIlse Lategan

Research Officer

ilse.lategan@gmail.com+27724943336

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026