Study of Energy Requirements in Critically Ill Newborns
Recruitment status was Recruiting
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Purpose
OBJECTIVES:
I. Determine the total energy expenditure in term and preterm infants in both well and ill states using the doubly labeled water method.
| Condition |
|---|
|
Respiratory Distress Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Natural History |
| Official Title: | Study of Energy Requirements in Critically Ill Newborns |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 1997 |
PROTOCOL OUTLINE: Patients are assigned to one of three groups according to gestational age (24-28 weeks estimated gestational age (EGA) vs 29-34 weeks EGA vs 35 weeks EGA and over) and severity of respiratory illness (need for high frequency ventilation vs stable conventional ventilator settings or extubated within past 24 hours vs no need for mechanical ventilation).
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.
Eligibility| Ages Eligible for Study: | up to 120 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202-5167 | |
| Contact: Catherine A. Leitch 317-274-4920 | |
| Study Chair: | Catherine A. Leitch | Indiana University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006274 History of Changes |
| Other Study ID Numbers: | NCRR-M01RR00750-9044, IU-9703-22 |
| Study First Received: | September 11, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Research Resources (NCRR):
|
cardiovascular and respiratory diseases neonatal disorders rare disease respiratory distress syndrome |
Additional relevant MeSH terms:
|
Critical Illness Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Disease Attributes Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on May 16, 2013