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| Tracking Information | |||||
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| First Received Date ICMJE | September 11, 2000 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | March 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006274 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Energy Requirements in Critically Ill Newborns | ||||
| Official Title ICMJE | Study of Energy Requirements in Critically Ill Newborns | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Natural History | ||||
| Condition ICMJE | Respiratory Distress Syndrome | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 60 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | up to 120 Hours | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006274 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NCRR-M01RR00750-9044, IU-9703-22 | ||||
| Study Sponsor ICMJE | National Center for Research Resources (NCRR) | ||||
| Collaborators ICMJE | Indiana University School of Medicine | ||||
| Investigators ICMJE |
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| Information Provided By | National Center for Research Resources (NCRR) | ||||
| Verification Date | December 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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