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

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05242107
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Lipid Profile; Neonates; Intrauterine Growth Restriction	Dietary Supplement: Omega-3 supplement group; Other: Full feeding without receiving any supplementation group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Role of Omega-3 Supplementation on Lipid Profile and Serum Leptin Level in Neonates With Intrauterine Growth Restriction
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Jan 1, 2022
• Actual Study Completion Date: Jan 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Day to 4 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta university	Tanta		Egypt

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mai Rabie El-Sheikh, Doctor, Tanta University
• ClinicalTrials.gov Identifier: NCT05242107
• Other Study ID Numbers: 35199/9/22
• First Posted: Feb 16, 2022
• Last Update Posted: Feb 16, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fetal Growth Retardation

Study Results

No Results Posted as of Feb 16, 2022