Esophageal Motility and Airway Defenses Among Infants - Full Text View

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Childrens Research Institute
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00062452

Purpose

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.

MedlinePlus related topics: Esophagus Disorders Premature Babies

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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):

Biospecimen Retention: None Retained

Biospecimen Description:

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
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.	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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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)

Childrens Research Institute

Investigators

Principal Investigator:

Sudarshan R Jadcherla, MD

Nationwide Children's Hospital/The Ohio State University College of Medicine

More Information

Publications of Results:

Jadcherla SR, Duong HQ, Hoffmann RG, Shaker R. Esophageal body and upper esophageal sphincter motor responses to esophageal provocation during maturation in preterm newborns. J Pediatr. 2003 Jul;143(1):31-8.

Jadcherla SR, Hoffmann RG, Shaker R. Effect of maturation of the magnitude of mechanosensitive and chemosensitive reflexes in the premature human esophagus. J Pediatr. 2006 Jul;149(1):77-82.

Jadcherla SR, Gupta A, Stoner E, Coley BD, Wiet GJ, Shaker R. Correlation of glottal closure using concurrent ultrasonography and nasolaryngoscopy in children: a novel approach to evaluate glottal status. Dysphagia. 2006 Jan;21(1):75-81.

Jadcherla SR. Manometric evaluation of esophageal-protective reflexes in infants and children. Am J Med. 2003 Aug 18;115 Suppl 3A:157S-160S.

Jadcherla SR, Duong HQ, Hofmann C, Hoffmann R, Shaker R. Characteristics of upper oesophageal sphincter and oesophageal body during maturation in healthy human neonates compared with adults. Neurogastroenterol Motil. 2005 Oct;17(5):663-70.

Gupta A, Jadcherla SR. The relationship between somatic growth and in vivo esophageal segmental and sphincteric growth in human neonates. J Pediatr Gastroenterol Nutr. 2006 Jul;43(1):35-41.

Responsible Party:	Nationwide Childrens Hospital/The Ohio State University College of Medicine ( Sudarshan R. Jadcherla, MD, Principal Investigator, Associate Professor )
Study ID Numbers:	EMADAI, RO3 DK 061502
Study First Received:	June 5, 2003
Last Updated:	January 21, 2008
ClinicalTrials.gov Identifier:	NCT00062452
Health Authority:	United States: Federal Government

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

Esophageal
Airway

Study placed in the following topic categories:

Death
Esophageal disorder
Wounds and Injuries
Infant, Newborn, Diseases
Disorders of Environmental Origin

Infant, Premature, Diseases
Esophageal Diseases
Congenital Abnormalities
Asphyxia

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009