Study of Energy Requirements in Critically Ill Newborns
NCT ID: NCT00006274
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
60 participants
OBSERVATIONAL
1997-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
I. Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Patients receive water labeled with deuterium and oxygen O 18 by mouth or by gastrostomy tube on days 1 and 7. Urine samples are collected prior to the first dose, 4-6 hours after the first dose, and then every 24 hours until the second dose. All urine is collected for 4-6 hours after the second dose. Samples are analyzed by dual inlet isotope ratio mass spectrometry.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NATURAL_HISTORY
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
24 Hours
120 Hours
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indiana University School of Medicine
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Catherine A. Leitch
Role: STUDY_CHAIR
Indiana University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Indiana University
Indianapolis, Indiana, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Catherine A. Leitch
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IU-9703-22
Identifier Type: -
Identifier Source: secondary_id
NCRR-M01RR00750-9044
Identifier Type: -
Identifier Source: org_study_id