NCT00006274

Brief Summary

OBJECTIVES: I. Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

September 11, 2000

Last Update Submit

June 23, 2005

Conditions

Respiratory Distress Syndrome

Keywords

cardiovascular and respiratory diseasesneonatal disordersrare diseaserespiratory distress syndrome

Eligibility Criteria

Age24 Hours - 120 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Infants with estimated gestational age (EGA) of at least 24 weeks with respiratory illness who are on high frequency ventilation (HFOV) and meet the following conditions: Appropriate size for gestational age (AGA) No congenital anomalies No medical complications, including seizures and necrotizing enterocolitis OR Control infants with EGA of at least 24 weeks Must meet 1 of the following conditions: Requirement for stable conventional ventilator settings with respiratory index score of less than 2.5 and/or extubated within past 24 hours No requirement for mechanical ventilation Must meet all of the following conditions: AGA No congenital anomalies No medical complications, including seizures and necrotizing enterocolitis No documented sepsis by positive blood culture No supplemental oxygen use (infants 35 weeks EGA and over only) --Prior/Concurrent Therapy-- HFOV group: Concurrent surfactant, theophylline, or inotrope (vasopressor) therapy allowed Control group: No concurrent inotrope (vasopressor) therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202-5167, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromeRespiratory Tract DiseasesInfant, Newborn, DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Lung DiseasesRespiration DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine A. Leitch

    Indiana University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Sponsor Type
NIH

Study Record Dates

First Submitted

September 11, 2000

First Posted

September 12, 2000

Study Start

March 1, 1997

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(1)