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

June 5, 2003
January 12, 2010
May 2002
April 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00062452 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Esophageal Motility and Airway Defenses Among Infants
Esophageal Motility and Airway Defenses Among Infants

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Premature infants congenital foregut anomalies Perinatal asphyxia

  • Infant, Premature, Diseases
  • Congenital Abnormalities
  • Perinatal Asphyxia
Other: This is not an interventional study.
The study was intended to evaluate esophageal motility mechanisms within the 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.
Intervention: Other: This is not an interventional study.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
July 2005
April 2005   (final data collection date for primary outcome measure)

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

Both
up to 6 Months
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00062452
EMADAI (completed), RO3 DK 061502
Yes
Sudarshan R. Jadcherla, MD, Principal Investigator, Associate Professor, Nationwide Childrens Hospital/The Ohio State University College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Childrens Research Institute
Principal Investigator: Sudarshan R Jadcherla, MD Nationwide Children's Hospital/The Ohio State University College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP