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

Not Applicable

Completed

• Conditions: Neonates; Lipid Profile; Intrauterine Growth Restriction
• Interventions: Dietary Supplement: Omega-3 supplement group; Other: Full feeding without receiving any supplementation group

• Registration Number: NCT05242107
• Lead Sponsor: Tanta University

Brief 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)

Detailed 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.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-10
• Status Verified: 2022-02
• Study First Submitted: 2022-02-07
• Study First Submitted QC: 2022-02-07
• Last Update Submitted: 2022-02-07
• Study First Posted: 2022-02-16
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omega-3 supplement group	Omega-3 supplement group	This group included 35 full term Intrauterine Growth Restriction( IUGR) neonates, who received omega-3 supplement (Docosa-hexa-enoic acid (DHA) 40 mg/kg/ day) after establishment of full feeding.
Full feeding without receiving any supplementation group	Full feeding without receiving any supplementation group	This group included 35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation.

Primary Outcome Measures

Name	Time	Method
Level of serum leptin	4 weeks from admission to neonatal intensive care unit	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).

Secondary Outcome Measures

Name	Time	Method
Level of serum lipid	4 weeks from admission to neonatal intensive care unit	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).

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Egypt