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

Tanta University

Status: Completed

Conditions: Lipid Profile; Neonates; Intrauterine Growth Restriction

Treatments: Other: Full feeding without receiving any supplementation group; Dietary Supplement: Omega-3 supplement group

Study type: Interventional

Funder types: Other

Identifiers

NCT05242107

35199/9/22

Details and patient eligibility

About

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)

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 1 day to 4 weeks old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Omega-3 supplement group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Omega-3 supplement group

Full feeding without receiving any supplementation group

Experimental group

Description:

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

Treatment:

Other: Full feeding without receiving any supplementation group