MedDataX Logo

Esophageal Motility and Airway Defenses Among Infants

NCT ID: NCT00062452

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-05-31

Study Completion Date

2005-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant, Premature, Diseases Congenital Abnormalities Perinatal Asphyxia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Weeks

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's National Research Institute

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sudarshan R Jadcherla, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Columbus Childrens Hospital

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 12915821 (View on PubMed)

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.

Reference Type RESULT
PMID: 16860132 (View on PubMed)

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.

Reference Type RESULT
PMID: 16786412 (View on PubMed)

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.

Reference Type RESULT
PMID: 12928093 (View on PubMed)

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.

Reference Type RESULT
PMID: 16185304 (View on PubMed)

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.

Reference Type RESULT
PMID: 16819375 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R03DK061502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EMADAI (completed)

Identifier Type: -

Identifier Source: org_study_id