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

Respiratory Insufficiency Clinical Trial

— Surfactant 2  

Official title:

Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250- 2000 Grams With RDS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005774
• Other study ID #: NICHD-NRN-0024
• Secondary ID: U10HD027856U10HD
• Status: Terminated
• Phase: Phase 3
• First received: June 1, 2000
• Last updated: June 3, 2015
• Start date: May 2000
• Est. completion date: July 2002

Study information

• Verified date: June 2015
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: July 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infant, Newborn
• Pulmonary Valve Insufficiency
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Drug:
• Early surfactant
Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)
• Standard practice
Surfactant according to current center practice, only after initiation of mechanical ventilation.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Wayne State University	Detroit	Michigan
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Tennessee	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
NICHD Neonatal Research Network	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for mechanical ventilation following randomization		Until hospital discharge or 120 days of life	Yes
Secondary	Mean duration of mechanical ventilation		Until hospital discharge or 120 days of life	Yes
Secondary	Risk morbidities associated with mechanical ventilation and/or early surfactant administration		Until hospital discharge or 120 days of life	Yes

External Links

•   NICHD Neonatal Research Network