Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2002-07-31

Brief Summary

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Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

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Detailed Description

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Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. The role of surfactant therapy in the management of larger infants with respiratory distress syndrome (RDS) was unclear. In many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (CPAP) alone.

This trial tested whether early use of surfactant combined with CPAP would ameliorate the course of RDS without an increased risk of death. Primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity.

Eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of CPAP (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group).

The trial was stopped after 7 months for lack of recruitment.

Conditions

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Infant, Newborn Respiratory Distress Syndrome Respiratory Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early surfactant group

Group Type EXPERIMENTAL

Early surfactant

Intervention Type DRUG

Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)

Standard Practice group

Group Type ACTIVE_COMPARATOR

Standard practice

Intervention Type DRUG

Surfactant according to current center practice, only after initiation of mechanical ventilation.

Interventions

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Early surfactant

Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)

Intervention Type DRUG

Standard practice

Surfactant according to current center practice, only after initiation of mechanical ventilation.

Intervention Type DRUG

Other Intervention Names

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Survanta

Eligibility Criteria

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Inclusion Criteria

* Infants born at 1,250-2g000 grams birth weight
* \<12 hours of age
* Clinical and radiographic diagnosis of respiratory distress syndrome (RDS)
* Receiving supplemental oxygen with head-hood Fi02 of 0.35 to 0.50 or CPAP Fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent

Exclusion Criteria

* Receiving mechanical ventilation
* Air leak
* Pulmonary hemorrhage
* Major congenital anomaly
* Congenital non-bacterial infection
* Parental refusal of consent
* Refusal of attending neonatologist

Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No