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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00062452
Other study ID # EMADAI (completed)
Secondary ID R03DK061502
Status Completed
Phase N/A
First received June 5, 2003
Last updated October 5, 2017
Start date May 2002
Est. completion date July 2005

Study information

Verified date January 2010
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date July 2005
Est. primary completion date April 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 6 Months
Eligibility 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

Study Design


Locations

Country Name City State
United States Columbus Childrens Hospital Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Children's Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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