Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Esophageal Motility and Airway Defenses Among Infants

This study has been completed.
Childrens Research Institute
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: June 5, 2003
Last updated: January 12, 2010
Last verified: January 2010

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 Intervention
Infant, Premature, Diseases
Congenital Abnormalities
Perinatal Asphyxia
Other: This is not an interventional study.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Esophageal Motility and Airway Defenses Among Infants

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Enrollment: 65
Study Start Date: May 2002
Study Completion Date: July 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Other: This is not an interventional study.
The study was intended to evaluate esophageal motility mechanisms within the cohort.

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.


Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Premature infants congenital foregut anomalies Perinatal asphyxia


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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00062452

United States, Ohio
Columbus Childrens Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Childrens Research Institute
Principal Investigator: Sudarshan R Jadcherla, MD Nationwide Children's Hospital/The Ohio State University College of Medicine
  More Information

Responsible Party: Sudarshan R. Jadcherla, MD, Principal Investigator, Associate Professor, Nationwide Childrens Hospital/The Ohio State University College of Medicine Identifier: NCT00062452     History of Changes
Other Study ID Numbers: EMADAI (completed), RO3 DK 061502
Study First Received: June 5, 2003
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Congenital Abnormalities
Infant, Premature, Diseases
Infant, Newborn, Diseases processed this record on March 03, 2015