Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants (Surfactant 2)

NICHD Neonatal Research Network

Status and phase: Terminated; Phase 3

Conditions: Respiratory Distress Syndrome; Infant, Newborn; Respiratory Insufficiency

Treatments: Drug: Standard practice; Drug: Early surfactant

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00005774

NICHD-NRN-0024

M01RR000997 (U.S. NIH Grant/Contract)

U10HD021415 (U.S. NIH Grant/Contract)

U10HD027853 (U.S. NIH Grant/Contract)

U10HD034167 (U.S. NIH Grant/Contract)

M01RR000070 (U.S. NIH Grant/Contract)

M01RR006022 (U.S. NIH Grant/Contract)

U10HD021364 (U.S. NIH Grant/Contract)

U10HD027880 (U.S. NIH Grant/Contract)

U10HD027856 (U.S. NIH Grant/Contract)

U10HD027851 (U.S. NIH Grant/Contract)

M01RR000750 (U.S. NIH Grant/Contract)

U10HD027881 (U.S. NIH Grant/Contract)

U10HD021397 (U.S. NIH Grant/Contract)

M01RR001032 (U.S. NIH Grant/Contract)

M01RR008084 (U.S. NIH Grant/Contract)

U01HD036790 (U.S. NIH Grant/Contract)

U10HD034216 (U.S. NIH Grant/Contract)

U10HD021385 (U.S. NIH Grant/Contract)

U10HD027904 (U.S. NIH Grant/Contract)

U10HD027871 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: Under 12 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

Early surfactant group

Experimental group

Treatment:

Drug: Early surfactant

Standard Practice group

Active Comparator group

Treatment:

Drug: Standard practice