Hypoglycemic and Hyperglycemic Disorders

Hyperglycemia Clinical Trial

Official title:

Glycemic Disorders in Low Birth Weight Babies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03448965
• Other study ID #: NGD
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2018
• Last updated: February 27, 2018
• Start date: December 15, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Assiut University
• Contact: samia atwa, prof
• Phone: 01223971326
• Email: Samia26[@]aun..edu.egs
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• All neonates admitted to neonatology unit

1. From 0-28 days

2. Weighting less than 2500gm

Exclusion Criteria:

• Any neonate weighting more than 2500 gm

Related Conditions & MeSH terms

• Hyperglycemia
• Hypoglycemia
• Hypoglycemia in Newborn Infants

Intervention

Diagnostic Test:
• random blood sugar
do random blood sugar at 0 hour - 2 hours- 4 hours and after 6 hours

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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