Impact of Surfactant's Availability on Newborns

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005432
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: November 2001
  Purpose

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)?


Condition
Lung Diseases
Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Natural History

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1995
Estimated Study Completion Date: December 1997
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00005432     History of Changes
Other Study ID Numbers: 4350
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 27, 2014