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Esophageal Motility and Airway Defenses Among Infants

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ClinicalTrials.gov Identifier: NCT00062452
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : October 6, 2017
Sponsor:
Collaborator:
Children's Research Institute
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease
Infant, Premature, Diseases Congenital Abnormalities Perinatal Asphyxia

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.

Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Esophageal Motility and Airway Defenses Among Infants
Study Start Date : May 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : July 2005

Group/Cohort
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.




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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Premature infants congenital foregut anomalies Perinatal asphyxia
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062452


Locations
United States, Ohio
Columbus Childrens Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Children's Research Institute
Investigators
Principal Investigator: Sudarshan R Jadcherla, MD Nationwide Children's Hospital/The Ohio State University College of Medicine

Publications of Results:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00062452     History of Changes
Other Study ID Numbers: EMADAI (completed)
R03DK061502 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2003    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: January 2010

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Esophageal
Airway

Additional relevant MeSH terms:
Asphyxia
Infant, Premature, Diseases
Congenital Abnormalities
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases