- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03448965
Hypoglycemic and Hyperglycemic Disorders
February 27, 2018 updated by: martinamamdouh fahem, Assiut University
Glycemic Disorders in Low Birth Weight Babies
Definition of low birth weight:
Low birth weight infants are those born weighing less than 2500 g. These are further subdivided into:
- Very Low Birth Weight : Birth weight <1,500 g
- Extremely Low Birth Weight : Birth weight <1,000 g Their survival is directly related to birth weight, with approximately 20% of those between 500 and 600 g and>90% of those between 1,250 and 1,500 g surviving. Perinatalcare has improved the rate of survival of low birth weight infants.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Causes of low birth weight:
- Premature birth
- Intrauterine growth restriction, which are most often Due to different placental problems and health problems of the mother or new-born
RISK FACTORS:
- Age: Teen mothers have a much higher risk of having VLBW infant.
- Multiple birth babies are at increased risk of being VLBW because they often are premature. More than 50% of twins and other multiple gestations are VLBW if <15 years
- Maternal health: Women exposed to drugs, alcohol, and cigarettes during pregnancy are more likely to have low birth weight babies. Mothers of lower socioeconomic
- Race: African-American babies are twice as likely as Caucasian to be very low birth weight
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
all low birth weight babies
Description
Inclusion Criteria:
All neonates admitted to neonatology unit
- From 0-28 days
- Weighting less than 2500gm
Exclusion Criteria:
- Any neonate weighting more than 2500 gm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
glycemic disorders in low birth weight
Time Frame: one year
|
to detect the prevelance of hypoglycemia and hyperglycemia in low birth weight babies by random blood sugar test
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Abdulkadir I, Hassan L, Abdullahi F, Sobowale AM, Akeredolu FD, Purdue S, Okpe M, Adewumi OA, Abdullahi U, Onadiran MA, Ogala WN. Outcome of Extremely Low Birth Weight Babies in Zaria; A Ten-Year Review. West Afr J Med. 2015 Jan-Mar;34(1):50-4.
- Hays SP, Smith EO, Sunehag AL. Hyperglycemia is a risk factor for early death and morbidity in extremely low birth-weight infants. Pediatrics. 2006 Nov;118(5):1811-8. doi: 10.1542/peds.2006-0628.
- Rozance PJ, Hay WW Jr. New approaches to management of neonatal hypoglycemia. Matern Health Neonatol Perinatol. 2016 May 10;2:3. doi: 10.1186/s40748-016-0031-z. eCollection 2016.
- Eichenwald EC, Stark AR. Management and outcomes of very low birth weight. N Engl J Med. 2008 Apr 17;358(16):1700-11. doi: 10.1056/NEJMra0707601. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 15, 2018
Primary Completion (Anticipated)
October 20, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
February 22, 2018
First Submitted That Met QC Criteria
February 27, 2018
First Posted (Actual)
February 28, 2018
Study Record Updates
Last Update Posted (Actual)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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