Evaluating the effect of increasing the amount of milk protein content by protein supplement on growth indices of preterm infants
Design
A concealed, randomized, blinded, clinical trial with a parallel group design of 30 patients, enrolled between March 2014 and March 2015. ّ
Settings and conduct
The study was conducted at Imam Khomeini Hospital's NICU in Tehran. Newborns were randomly divided into two groups. By enteral feeding beginning we have added protein supplement to reach 4 grams per kilogram per day as total protein receiving per day which compare to the Control group who has taken 3.5 grams per kilogram per day protein with their enteral feeding. Its effects on neonatal growth indices, days of hospitalization, full fed time were recorded. Double-blinded study, which the patients, the nurses, the conductors, and the analyst _who later joined the research team and was not a member initially _ were not aware.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Gestational age less than 34 weeks; Birth weight less than 1500 grams. Exclusion criteria: Growth affecting anomalies; Parents disapproval; Unable to continue feeding for more than 72 hours; Urea over than 60 milligram per deciliter
Intervention groups
Participant in intervention group are premature infants born < 32 complete week's gestational and birthweight les than 1500 gram who will receive high protein diet, reaching the goal of 4 grams per kilogram per day.
Participant in intervention group are also premature infants born < 32 complete week's gestational and birthweight les than 1500 gram who will receive standard protein diet which is 3.5 grams per kilogram per day.
All participants' growth indices, days of hospitalization and full fed time were recorded.
Main outcome variables
Growth indices; Length of hospitalization; Oral tolerance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141118019991N3
Registration date:2021-09-16, 1400/06/25
Registration timing:retrospective
Last update:2021-09-16, 1400/06/25
Update count:0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Saharnaz Talebiyan
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2407
Email address
s_talebiyan@yahoo.com
Recruitment status
Recruitment complete
Funding source
TEHRAN UNIVERSITY OF MEDICAL SCIENCE
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
2014-03-20, 1392/12/29
Actual recruitment end date
2015-03-20, 1393/12/29
Trial completion date
2015-03-20, 1393/12/29
Scientific title
Evaluating the effect of increasing the amount of milk protein content by protein supplement on growth indices of preterm infants
Public title
Effect of increasing the amount of milk protein content by protein supplement on growth indices of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age less than 34 weeks
Birth weight less than 1500 grams
No anomalies which affect on growth
Exclusion criteria:
Parents disapproval
Unable to continue feeding more than 72 hours
Urea over than 50 milligram per deciliter
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We will Use permuted block randomization and assign participants 1:1 to the standard of care diet (control) or higher protein Diet (intervention).
Twins will be randomized individually. The study biostatistician will generate the allocation sequence and place the research assignments in envelopes, to be opened by research assistants on the study start date.
Blinding (investigator's opinion)
Double blinded
Blinding description
Parents, clinical staff, and all study staff apart from the research assistants who prepare the study diet will be blinded to the study group. Unblinding will be permitted if an error in milk preparation is identified, or if unexpected safety concerns arise that require unblinding.
Clinical and Para-clinical sign of Necrotizing Enterocolitis
Timepoint
Multiple clinical Evaluation per day, and if needed also Para-clinical evaluation
Method of measurement
Clinical and Para-clinical Signs and symptoms.
9
Description
Sepsis Early or Late Onset, clinical or Para-clinical Sign and Symptoms.
Timepoint
Multiple clinical Evaluation per day, and if needed also Para-clinical evaluation
Method of measurement
Clinical and Para-clinical Signs and Symptoms
10
Description
Hospitalization Duration
Timepoint
Hospitalization Duration by days number at discharge.
Method of measurement
Hospitalization Duration days
Intervention groups
1
Description
Intervention group: High protein diet (4 grams per kilogram per day) which is provided by protein supplement, when the enteral feeding has been started.
Category
Treatment - Other
2
Description
Control group: Routine protein diet (3.5 grams per kilogram per day) which is provided by protein supplement, when the enteral feeding has been started.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Breastfeeding research center Tehran university of medical sciences