Impact of Surfactant's Availability on Newborns

To identify what happened to specific groups of newborns after surfactant was introduced to the market. Were the same benefits with regard to morbidity, mortality, and resource use in evidence post treatment investigational new drug (IND)?

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Respiratory Distress Syndrome

Detailed Description

BACKGROUND:

The clinical trial literature on surfactant clearly demonstrated that surfactant therapy resulted in improved early respiratory status and improved mortality rates for premature newborns infants suffering from respiratory ailments due to surfactant insufficiency. However, the clinical trial experience regarding efficacy did not ensure that the same benefits would be conferred on patients outside the clinical trial environment during routine medical care.

DESIGN NARRATIVE:

The investigators had already demonstrated in an epidemiological study published in the New England Journal of Medicine (May 1994) that morbidity, mortality, and resource use among very low birth weight inborn infants declined once surfactant became available. This study broadened the focus to include infants excluded from the original study. The hypotheses for the study centered on the investigators' belief that infants who were in the 1500 to 2500 gram weight group also experienced reduced mortality, morbidity, and resource use post-surfactant, as did those who were mature with severe respiratory disease, and those who were outborn i.e. those who were transferred to a perinatal center. Finally, because of the significant focus on health care reform and quality assurance in clinical care the investigators included a hypothesis focusing on the impact of payer on mortality, morbidity, and resource use. The original study identified that the payer was not a factor differentiating the newborns with regard to any measures of outcome or resource use. The investigators hypothesized that this would remain the case. However, they suspected that there might be some indications in their analysis among patients who were outborn that HMO or managed care was influencing not only where births were occurring, but how well fragile newborns did in the clinical environment. All the analyses used analytic datafiles from the National Perinatal Information Center's Perinatal Center Database. A pre-and post-surfactant period was created using eleven perinatal centers who provided data on all newborns from 1985 and 1992. Infants were divided into two groups according to whether they were born before or after surfactant was introduced into clinical practice. Regression models controlling for race, sex, and birthweight were used to assess morbidity, mortality, and resource use.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

No eligibility criteria

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start: May 1, 1995
• Study Completion (Actual): December 1, 1997

Study Registration Dates

• First Submitted: May 25, 2000
• First Submitted That Met QC Criteria: May 25, 2000
• First Posted (Estimate): May 26, 2000

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: November 1, 2001

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Infant, Newborn, Diseases; Infant, Premature, Diseases; Lung Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 4350 (PCORI); R03HL054331 (U.S. NIH Grant/Contract)