Esophageal Motility and Airway Defenses Among Infants
This study has been completed.
Sponsor:
Collaborator:
Childrens Research Institute
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00062452
First received: June 5, 2003
Last updated: January 12, 2010
Last verified: January 2010
| Tracking Information | |||||
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| First Received Date ICMJE | June 5, 2003 | ||||
| Last Updated Date | January 12, 2010 | ||||
| Start Date ICMJE | May 2002 | ||||
| Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00062452 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Esophageal Motility and Airway Defenses Among Infants | ||||
| Official Title ICMJE | Esophageal Motility and Airway Defenses Among Infants | ||||
| Brief Summary | Feeding difficulties and airway related consequences contribute significantly to the infant mortality and morbidity. Some of these problems may be dependent on neural control and muscular function. Prematurity, congenital anomalies and perinatal depression represent three important conditions in infants, that may have feeding and airway difficulties.Development of motility of the foregut and the adaptation during normal and disease in developing infants is unclear. |
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| Detailed Description | With the aid of small clinical research funding from the NIDDK, in this proposal, we have developed methods to safely evaluate foregut motility in relation to breathing among high risk infants. We are using simultaneous esophageal motility studies, swallowing and respiratory measurements in this evaluation. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Premature infants congenital foregut anomalies Perinatal asphyxia |
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| Condition ICMJE |
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| Intervention ICMJE | Other: This is not an interventional study.
The study was intended to evaluate esophageal motility mechanisms within the cohort. |
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| Study Group/Cohort (s) | A-1,2,3
The cohort (A) comprised of high risk infants. There were 3 sub groups studied within this cohort: (1) premature infants, (2) Infants with congenital gut anomalies, and (3) perinatal asphyxia.
Intervention: Other: This is not an interventional study. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 65 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Prematurely born infants, Infants with congenital foregut anomalies, Infants with perinatal asphyxia, Ability to maintain vital signs at study, Exclusion Criteria: No contraindication to enteral feeding |
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| Gender | Both | ||||
| Ages | up to 6 Months | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00062452 | ||||
| Other Study ID Numbers ICMJE | EMADAI (completed), RO3 DK 061502 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Sudarshan R. Jadcherla, MD, Principal Investigator, Associate Professor, Nationwide Childrens Hospital/The Ohio State University College of Medicine | ||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Collaborators ICMJE | Childrens Research Institute | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Verification Date | January 2010 | ||||
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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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