Omega-3 on Lipid Profile and Serum Leptin Level n Neonates With Intrauterine Growth Restriction

Intrauterine Growth Restriction Clinical Trial

Official title:

Role of Omega-3 Supplementation on Lipid Profile and Serum Leptin Level in Neonates With Intrauterine Growth Restriction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05242107
• Other study ID #: 35199/9/22
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: February 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study will demonstrate the effect of omega 3 supplementation on serum lipid profile level and leptin level in neonates with Intrauterine Growth Restriction( IUGR)

Description:

Intrauterine growth restriction is a major cause of perinatal mortality and morbidity .

It is noted to affect approximately 5-15 % of pregnant women. Egypt has one of the highest incidences of Intrauterine Growth Restriction. The incidence of IUGR varies among countries, populations, races and increases with decreasing gestational age. 14 to 20 million infants have been affected with Intrauterine Growth Restriction cases in the developing countries annually.

A complex and dynamic interaction of maternal, placental and fetal environment is involved in ensuring normal fetal growth. An imbalance or lack of coordination in this complex system may lead to Intrauterine Growth Restriction. Intrauterine Growth Restriction( IUGR) results in significant perinatal and long-term complications, including increased neonatal mortality and morbidity and higher risk for developing metabolic syndrome later in life.

Physiological differences have been noted in growth restricted infants. Intrauterine amino acid disturbances similar to biochemical changes seen in postnatal protein deprived states have been detected. Protein metabolism defect and altered lipid metabolism also have been described.

Undernourishment in utero appears to be associated with persisting changes in the metabolic functions. Birth weight influences the lipoprotein profile and cholesteryl ester transfer protein, which promotes a proatherogenic lipoprotein profile in plasma by determining chemical, physical and biological properties of the respective lipoprotein particle in neonates.

Recent research suggests that several of major disease of later life, including coronary heart disease, hypertension & type II diabetes originate in impaired intrauterine growth and development. These diseases may be consequence of programming whereby a stimulus or insult at a critical, sensitive period of early life has a permanent effect on structure, physiology and metabolism.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 10, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

• Any full-term Intrauterine growth restriction (IUGR) neonate

Exclusion Criteria:

• Preterm neonates

• Who died before feeding was established

• Multiple congenital anomalies including GIT anomalies

• Congenital infection

• Cholestasis

• Infant of diabetic mother (IDM)

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Intrauterine Growth Restriction
• Lipid Profile
• Neonates

Intervention

Dietary Supplement:
• Omega-3 supplement group
35 Neonates were given Omega 3 in a dose of 40mg/kg/day (8), after establishment of full-feeding and for 2 weeks duration. Omega-300 (Montana pharmaceutical industry) capsule was used which contains 1000mg Omega 3 fatty acids.

Other:
• Full feeding without receiving any supplementation group
35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation.

Locations

Country	Name	City	State
Egypt	Tanta university	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of serum leptin	Effect of omega 3 (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day)supplementation on level of serum leptin in neonates with Intrauterine growth restriction (IUGR).	4 weeks from admission to neonatal intensive care unit
Secondary	Level of serum lipid	Effect of omega 3 (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day) supplementation on level of serum lipid in neonates with Intrauterine growth restriction (IUGR).	4 weeks from admission to neonatal intensive care unit