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

University of Cologne

Status: Completed

Conditions: Respiratory Distress Syndrome, Newborn

Treatments: Drug: Curosurf

Study type: Interventional

Funder types: Other

Identifiers

NCT00751959

Uni-Koeln-439

ISRCTN64011614 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 213 patients

Sex: All

Ages: 23 to 26 weeks old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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213 participants in 2 patient groups

2

Active Comparator group

Description:

Conventional therapy with intubation, initiation of mechanical ventilation and surfactant application

Treatment:

Drug: Curosurf

Drug: Curosurf

1

Experimental group

Description:

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

Treatment:

Drug: Curosurf

Drug: Curosurf