Electrogastrography in Small for Gestational Age Preterm Infants
This study has been completed.
Sponsor:
Meir Medical Center
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00819715
First received: January 8, 2009
Last updated: October 10, 2010
Last verified: June 2009
| Tracking Information | |||||
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| First Received Date ICMJE | January 8, 2009 | ||||
| Last Updated Date | October 10, 2010 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
EGG compatible with age [ Time Frame: day 1 and day 7 after birth ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00819715 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Electrogastrography in Small for Gestational Age Preterm Infants | ||||
| Official Title ICMJE | Electrogastrography in Small for Gestational Age Preterm Infants Compared to Appropriate for Gestational Age Infants | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Preterm infants >31 weeks, - 37 weeks , healthy, on enteralfeeds |
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| Condition ICMJE | Premature Birth | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | 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 Pt 1):G503-8. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 2 Days | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00819715 | ||||
| Other Study ID Numbers ICMJE | 0244-07-MMC | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Mrs. Leah Cohen, Meir Medical Center | ||||
| Study Sponsor ICMJE | Meir Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Meir Medical Center | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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