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NCT Number: NCT05242107

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

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)

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Level of serum leptin

    Time frame: 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 outcomes

  1. Level of serum lipid

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Role of Omega-3 Supplementation on Lipid Profile and Serum Leptin Level in Neonates With Intrauterine Growth Restriction

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2022
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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