Investigating the effect of adding whey protein to the diet of nursing mothers in the first week after delivery in the prevention of severe physiologic jaundice in full term infant
Assessing the severity of physiological jaundice in term infants in the control group and the intervention group
Comparing of the severity of physiological jaundice in term infants in two groups
Design
The clinical trial consists of a control group and an intervention group. Sampling is non-random, convenience(available sample). Allocation of participants to two groups is performed using a randomized block design with RAS software. Each group consists of 50 participants, for a total of 100 participants.
Settings and conduct
Pregnant women in the last month of pregnancy who referred to the pregnancy clinic of Mahdieh Hospital were selected. The control group received their usual diet after delivery and recorded it daily. The intervention group consumed a serving of whey protein equivalent to 2 tablespoons in a glass of warm water in the morning on an empty stomach, and other nutritional items remained unchanged. The mother's daily diet was also recorded. The two groups were homogenized in terms of risk factors such as diabetes in the mother. Infants in both groups were followed up on the first day and the fifth day of birth for the occurrence of jaundice. Jaundice screening was performed by a nurse using a skin test.
Participants/Inclusion and exclusion criteria
Inclusion criteria: term newborns - Written consent from parents
Non inclusion criteria: hospitalization of the infant on the first day
of birth due to icterus
Intervention groups
The control group received their usual diet after delivery and recorded the diet plan daily.
After delivery, the intervention group consumed a simple whey protein meal equivalent to 2 tablespoons in a glass of warm water in the morning on an empty stomach for 5 days. Their other nutritional sources remained unchanged and recorded the diet plan daily.
Main outcome variables
Skin bilirubin determination; Weighing the baby
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058522N1
Registration date:2023-12-01, 1402/09/10
Registration timing:registered_while_recruiting
Last update:2023-12-01, 1402/09/10
Update count:0
Registration date
2023-12-01, 1402/09/10
Registrant information
Name
Farzaneh Khosropour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5697 1068
Email address
khosropoor67@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-31, 1402/08/09
Expected recruitment end date
2024-04-28, 1403/02/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of adding whey protein to the diet of nursing mothers in the first week after delivery in the prevention of severe physiologic jaundice in full term infant
Public title
Investigating the effect of adding whey protein in the prevention of severe physiologic jaundice in full term infant
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy term newborns (gestational age more than 37 weeks)
Written consent from parents
Exclusion criteria:
Hospitalization of the infant on the first day of birth due to icterus
Age
From 1 day old to 1 day old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Measurement of skin bilirubin on the first day of birth and 5 days after the intervention
Method of measurement
Standard skin bilirubin measurement device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The mother consumes a daily serving of simple whey protein equivalent to 2 tablespoons (20 grams) from Olida company in a glass of warm water in the morning on an empty stomach for 5 days after giving birth.