NCT03448965

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Status
unknown

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

First Submitted

Initial submission to the registry

February 22, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

February 22, 2018

Last Update Submit

February 27, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • glycemic disorders in low birth weight

    to detect the prevelance of hypoglycemia and hyperglycemia in low birth weight babies by random blood sugar test

    one year

Interventions

random blood sugarDIAGNOSTIC_TEST

do random blood sugar at 0 hour - 2 hours- 4 hours and after 6 hours

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

all low birth weight babies

You may qualify if:

  • All neonates admitted to neonatology unit
  • From 0-28 days
  • Weighting less than 2500gm

You may not qualify if:

  • Any neonate weighting more than 2500 gm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 26902817BACKGROUND
  • 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.

    PMID: 17079549BACKGROUND
  • 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.

    PMID: 27168942BACKGROUND
  • 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.

    PMID: 18420502BACKGROUND

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

samia atwa, prof

CONTACT

hekma farghaly

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

February 22, 2018

First Posted

February 28, 2018

Study Start

December 15, 2018

Primary Completion

October 20, 2019

Study Completion

December 31, 2019

Last Updated

February 28, 2018

Record last verified: 2018-02