Surfactant Application During Spontaneous Breathing With Continuous Positive Airway Pressure (CPAP) in Premature Infants < 27 Weeks

Surfactant Application During Spontaneous Breathing With CPAP or During Mechanical Ventilation in the Therapy of IRDS in Premature Infants < 27 Weeks

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751959

Acronym

NINSAPP

Enrollment

213

Registered

2008-09-12

Start date

2009-04-30

Completion date

2012-06-30

Last updated

2012-07-19

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

Conditions

Respiratory Distress Syndrome, Newborn

Keywords

Continuous positive airway pressure (CPAP), extremely preterm infant, Idiopathic respiratory distress syndrome (IRDS), Surfactant

Brief summary

This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.

Detailed description

80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.

Interventions

DRUGCurosurf

Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 26 Weeks

Healthy volunteers

Inclusion criteria

* IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3 * Postnatal age of more than 10 min. and less than 2 hours * Gestational age ≥ 23+0 and \< 27+0

Exclusion criteria

* Primary cardio- pulmonary resuscitation * Prenatally diagnosed severe malformation * No parental consent * Participation in another interventional trial

Design outcomes

Primary

Measure	Time frame
Survival until term without CLD	13-17 weeks after birth

Secondary

Measure	Time frame
Survival until term without CLD, IVH>II°, cystic PVL, ROP with need for surgery	13-17 weeks after birth

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026