NCT00819715

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 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

June 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 9, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

October 13, 2010

Status Verified

June 1, 2009

Enrollment Period

1.6 years

First QC Date

January 8, 2009

Last Update Submit

October 10, 2010

Conditions

Premature Birth

Keywords

Preterm infantssmall for gestational ageelectrogastrography

Outcome Measures

Primary Outcomes (1)

  • EGG compatible with age

    day 1 and day 7 after birth

Study Arms (2)

1

Small for gestational age preterm infants

2

Appropriate for gestational preterm infants

Eligibility Criteria

Age1 Day - 2 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • GE reflux
  • Medication that affect gastric motility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Department,Meir Medical Center

Kfar Saba, 44281, Israel

Location

Related Publications (1)

  • Liang J, Co E, Zhang M, Pineda J, Chen JD. Development of gastric slow waves in preterm infants measured by electrogastrography. Am J Physiol. 1998 Mar;274(3):G503-8. doi: 10.1152/ajpgi.1998.274.3.G503.

    PMID: 9530151RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Shmuel Arnon, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 9, 2009

Study Start

June 1, 2008

Primary Completion

January 1, 2010

Last Updated

October 13, 2010

Record last verified: 2009-06

Locations

IL(1)