Clinical trial NCT05242107: Omega-3 on Lipid Profile and Serum Leptin Level n Neonates With Intrauterine Growth Restriction
Official title: Role of Omega-3 Supplementation on Lipid Profile and Serum Leptin Level in Neonates With Intrauterine Growth Restriction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipid Profile
Neonates
Intrauterine Growth Restriction
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Level of serum leptin
timeFrame: 4 weeks from admission to neonatal intensive care unit
Secondary outcomes:
measure: Level of serum lipid
timeFrame: 4 weeks from admission to neonatal intensive care unit
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
References: