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

NCT ID: NCT05242107

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-01-10

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.

Conditions

Lipid Profile; Neonates; Intrauterine Growth Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Omega-3 supplement group

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Full feeding without receiving any supplementation group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 4 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mai Rabie El-Sheikh

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta university

Tanta, , Egypt

Countries

Egypt

References

Elsheikh M, El Amrousy D, El-Mahdy H, Dawoud H, Harkan A, El-Barky A. Lipid profile after omega-3 supplementation in neonates with intrauterine growth retardation: a randomized controlled trial. Pediatr Res. 2023 Oct;94(4):1503-1509. doi: 10.1038/s41390-023-02632-z. Epub 2023 May 18.

Reference Type: DERIVED

PMID: 37202530 (View on PubMed)

Other Identifiers

35199/9/22

Identifier Type: -

Identifier Source: org_study_id