CClinicalTrials.gg
Sign In
Status unknownNCT03448965Updated Feb 28, 2018

Hypoglycemic and Hyperglycemic Disorders

An observational study in Hypoglycemia in Newborn Infants and Hyperglycemia, sponsored by Assiut University. Status unknown. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
Up to 28 Days
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Hypoglycemia in Newborn Infants
  • Hyperglycemia
03

Who can participate

Ages eligible
Up to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

all low birth weight babies

Inclusion criteria

  • All neonates admitted to neonatology unit

    1. From 0-28 days
    2. Weighting less than 2500gm

Exclusion criteria

Exclusion Criteria:

  • Any neonate weighting more than 2500 gm
04

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testrandom blood sugar

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

05

What researchers measure

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

    Time frame: one year

06

Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 26902817 ↗
  • 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. PubMed 17079549 ↗
  • 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. PubMed 27168942 ↗
  • 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. PubMed 18420502 ↗
08

Registry details

Key details

Study ID
NCT03448965
Lead sponsor
Assiut University
Responsible party
martinamamdouh fahem (principle investigator, Assiut University) — Principal investigator
First posted
Feb 28, 2018
Start date
Dec 15, 2018 (estimated)
Primary completion
Oct 20, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Feb 28, 2018

Study contacts

samia atwa, prof
Contact
Samia26@aun..edu.egs
01223971326
hekma farghaly
Contact
hekma@aun.edu.eg
01091251040

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypoglycemia→

Other studies from this sponsor

Assiut University

Start the discussion