The effect of medium chain triglyceride oil in the treatment of neonatal jaundice
Design
74 neonates will be divided into two groups ,37 neonates in intervention group , 37 neonates in Control group. This study is a clinical trial ,double blind, simple randomized(computer randomization list) , phase 3.
Settings and conduct
Infants admitted to Imam Reza Hospital in Mashhad with a gestational age of more than 37 weeks, birth weight of more than 2500 grams, which are indicated for phototherapy are included in the study. With the help of computer randomization list, they are divided into two groups. One group is prescribed triglyceride oil (intervention) and the control group is prescribed distilled water (placebo). It is a double blind study in which parents and researchers do not know the type of drug and the drug is coded as A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gestational age more than 37 weeks, birth weights more than 2500 grams and indication of phototherapy.
Exclusion Criteria: Blood group and RH incompatibility, Low Apgar, subgaleal hemorrhage, cephal hematoma, congenital anomaly, infection, gastrointestinal obstruction and cholestasis, heart failure , renal failure, blood exchange .
Intervention groups
interventional group will receive Medium-Chain Triglycerides (Nutricia) orally 3 cc / kg as a single dose.
control group will receive placebo(distilled water) orally 3 cc/kg as a single dose.
Main outcome variables
serum bilirubin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001162N26
Registration date:2020-11-21, 1399/09/01
Registration timing:registered_while_recruiting
Last update:2020-11-21, 1399/09/01
Update count:0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
Ashraf Mohammadzadeh
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1852 1121
Email address
mohamadzadeha@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral Medium-Chain Triglyceride oil in the treatment of hyperbillirubinemia in term neonates
Public title
Effect of triglyceride oil on the treatment of neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
gestational age more than 37 weeks
Birth weight more than 2500 grams
Indication of phototherapy
Exclusion criteria:
Congenital anomaly
infection
Gastrointestinal obstruction and cholestasis
Heart failure
blood exchange
Renal failure
blood group or Rh incompatibility
Low Apgar
Subgaleal hemorrhage
Cephal hematoma
Age
From 1 day old to 30 days old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method is used. This method is done through a table of random numbers using the site www.randomization.com. The numbers are placed in sealed envelopes and with the arrival of patients, an envelope is assigned to each of them, which will be placed in one of the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study in which the researcher and the patient do not know about the type of drug and the drug is coded as A and B. After collecting the data, the codes are opened and the drug and placebo are identified
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences