NCT00062452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

October 6, 2017

Status Verified

January 1, 2010

Enrollment Period

2.9 years

First QC Date

June 5, 2003

Last Update Submit

October 5, 2017

Conditions

Keywords

EsophagealAirway

Study Arms (1)

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.

Eligibility Criteria

Age2 Weeks - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Premature infants congenital foregut anomalies Perinatal asphyxia

You may qualify if:

  • Prematurely born infants, Infants with congenital foregut anomalies, Infants with perinatal asphyxia, Ability to maintain vital signs at study,

You may not qualify if:

  • No contraindication to enteral feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbus Childrens Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (6)

  • 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. doi: 10.1016/S0022-3476(03)00242-7.

  • 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. doi: 10.1016/j.jpeds.2006.02.041.

  • 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. doi: 10.1007/s00455-005-9002-7.

  • Jadcherla SR. Manometric evaluation of esophageal-protective reflexes in infants and children. Am J Med. 2003 Aug 18;115 Suppl 3A:157S-160S. doi: 10.1016/s0002-9343(03)00215-8.

  • 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. doi: 10.1111/j.1365-2982.2005.00706.x.

  • 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. doi: 10.1097/01.mpg.0000226368.24332.50.

MeSH Terms

Conditions

Infant, Premature, DiseasesCongenital Abnormalities

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Sudarshan R Jadcherla, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

May 1, 2002

Primary Completion

April 1, 2005

Study Completion

July 1, 2005

Last Updated

October 6, 2017

Record last verified: 2010-01

Locations