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

NCT05242107 | Completed

• 1 other identifier: 35199/9/22
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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)

Conditions

Lipid Profile; Neonates; Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Level of serum lipid

  4 weeks from admission to neonatal intensive care unit

Study Arms (2)

Omega-3 supplement group

EXPERIMENTAL

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.

Dietary Supplement: Omega-3 supplement group

Full feeding without receiving any supplementation group

EXPERIMENTAL

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

Other: Full feeding without receiving any supplementation group

Interventions

Omega-3 supplement group 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.

Omega-3 supplement group

Full feeding without receiving any supplementation group OTHER

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

Full feeding without receiving any supplementation group

Eligibility Criteria

• Age: 1 Day - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Preterm neonates
• Who died before feeding was established
• Multiple congenital anomalies including GIT anomalies
• Congenital infection
• Cholestasis
• Infant of diabetic mother (IDM)

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Egypt

Location

Related Publications (1)

• 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.

  PMID: 37202530 DERIVED

MeSH Terms

Conditions

Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 16, 2022
• Study Start: June 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 10, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year after the end of the study

Locations

EG (1)