Omega-3 on Lipid Profile and Serum Leptin Level n Neonates With Intrauterine Growth Restriction
Primary Purpose
Lipid Profile, Neonates, Intrauterine Growth Restriction
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Omega-3 supplement group
Full feeding without receiving any supplementation group
Sponsored by
About this trial
This is an interventional treatment trial for Lipid Profile
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)
Sites / Locations
- Tanta university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Omega-3 supplement group
Full feeding without receiving any supplementation group
Arm 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.
This group included 35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05242107
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Profile, Neonates, Intrauterine Growth Restriction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega-3 supplement group
Arm Type
Experimental
Arm 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.
Arm Title
Full feeding without receiving any supplementation group
Arm Type
Experimental
Arm Description
This group included 35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 supplement group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Full feeding without receiving any supplementation group
Intervention Description
35 full term Growth Restriction( IUGR) neonates who were followed up to full feeding without receiving any supplementation.
Primary Outcome Measure Information:
Title
Level of serum leptin
Description
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
Secondary Outcome Measure Information:
Title
Level of serum lipid
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Tanta university
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study will be available upon a reasonable request from the corresponding author
IPD Sharing Time Frame
one year after the end of the study
Learn more about this trial
Omega-3 on Lipid Profile and Serum Leptin Level n Neonates With Intrauterine Growth Restriction
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