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Electrogastrography in Small for Gestational Age Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00819715
First received: January 8, 2009
Last updated: October 10, 2010
Last verified: June 2009
History of Changes
  Purpose

The purpose of this study is to determine whether small for gestational preterm infants, have delayed or decrease gastric motility compared to appropriate for gestational age preterm infants.


Condition
Premature Birth

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrogastrography in Small for Gestational Age Preterm Infants Compared to Appropriate for Gestational Age Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • EGG compatible with age [ Time Frame: day 1 and day 7 after birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2008
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Small for gestational age preterm infants
2
Appropriate for gestational preterm infants

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Preterm infants >31 weeks, - 37 weeks , healthy, on enteralfeeds

Criteria

Inclusion Criteria:

  1. preterm infants 32-37 weeks' gestation
  2. No sepsis or ventilation
  3. Feeding orally or with NG tube.
  4. Age <48 h to be included

Exclusion Criteria:

  1. GE reflux
  2. Medication that affect gastric motility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819715

Locations
Israel
Neonatal Department,Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Shmuel Arnon, MD Meir Medical Center
  More Information

Publications:

Responsible Party: Mrs. Leah Cohen, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00819715     History of Changes
Other Study ID Numbers: 0244-07-MMC
Study First Received: January 8, 2009
Last Updated: October 10, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Preterm infants
small for gestational age
electrogastrography

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 22, 2013