An interventional study of Omega-3 supplement group and Full feeding without receiving any supplementation group in Lipid Profile, Neonates and Intrauterine Growth Restriction, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 1 Day to 4 Weeks. Per ClinicalTrials.gov, last updated 2022-02-16.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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)
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's enrollment of 70 is below the median of 101 across 117 interventional studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
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Exclusion Criteria:
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
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 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.
35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation.
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).
Time frame: 4 weeks from admission to neonatal intensive care unit
Level of serum lipid
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).
Time frame: 4 weeks from admission to neonatal intensive care unit
Plan to share: Yes — The study will be available upon a reasonable request from the corresponding author
Supporting information: Study protocol
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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