Evaluating the effect of oropharyngeal colostrum administration from the first day of life in very low birth weight premature infant
Design
A concealed, randomized, blinded, clinical trial with a parallel group design of 50 patients, enrolled between November 2019 and November 2020.
2-3 RCT Phase.
Settings and conduct
The study was conducted at Shohada-e-Tajrish Hospital's NICU in Tehran. Newborn babies were randomly divided into two groups.Group Control was performed Minimal Enteral Feeding after 72 hours of birth and exposure group was received 0.2 cc breast milk (colostrum) every 3 hours orally from the first hours after birth. 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
Birth Weight lower than 1500 grams; Birth Weight beyond 1500 grams
Gestational Age lower than 32 weeks; Gestational Age more than 32 weeks
Newborn without congenital abnormalities; congenital anomalies
Newborn without Asphyxia; Asphyxiated
Intervention groups
Newborn babies were randomly divided into two groups.Group Control was performed Minimal Enteral Feeding after 72 hours of birth and exposure group was received 0.2 cc breast milk (colostrum) every 3 hours orally from the first hours after birth. Its effects on neonatal growth indices, infections, Hospital duration, full fed time and mortality will be recorded.
Evaluating the effect of oropharyngeal colostrum administration from the first day of life in very low birth weight premature infant
Public title
Evaluating the effect of oropharyngeal colostrum in very low birth weight premature infant.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Birth Weight lower than 1500 grams
Gestational Age lower than 32 weeks
Infant without congenital abnormalities.
No evidence of asphyxia.
Exclusion criteria:
Birth Weight more than 1500 grams.
Gestational Age more than 32 weeks.
Infant with congenital abnormalities.
Infant with asphyxia.
Need for resuscitation after birth.
Drug Abuser mother.
Mother who has HIV positive test.
Mothers who are Cytomegal Virus seropositive
Age
From 1 day old to 1 day old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Utilizing "RAS", permuted randomization was conducted on the sample population. Permuted Block Randomization of the Individual type was performed. The allocation concealment was done by The Data Safety and Monitoring Center of Shohadaye Tajrish Hospital's Clinical Research Development Department.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was a double-blinded study in 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 of the sampling procedures and the method by which randomly chosen treatments were administered to the patients.The method was carried out and authorized by "The Safety and Monitoring Committee."
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
Street address
Shohada Hospital, Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Approval date
2019-07-06, 1398/04/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.133
Health conditions studied
1
Description of health condition studied
Sepsis
ICD-10 code
A41.9
ICD-10 code description
Sepsis, unspecified organism
2
Description of health condition studied
Narcotizing Enterocolitis
ICD-10 code
P77.9
ICD-10 code description
Necrotizing enterocolitis in newborn, unspecified
3
Description of health condition studied
Mortality
ICD-10 code
R99
ICD-10 code description
Ill-defined and unknown cause of mortality
4
Description of health condition studied
Hospitalization Duration
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Full Fed time
ICD-10 code
ICD-10 code description
Primary outcomes
1
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
2
Description
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.
3
Description
Hospitalization Duration
Timepoint
Hospitalization Duration by days number at discharge.
Method of measurement
Hospitalization Duration
Secondary outcomes
1
Description
Mortality
Timepoint
the time of Dead
Method of measurement
Vital sign not recorded and no respond to Resuscitation
2
Description
Weight gain progress
Timepoint
Daily
Method of measurement
SEGA digital scale
3
Description
The time to reach full enteral feeding (120 cc / kg)
Timepoint
Daily
Method of measurement
It was calculated every day by the neonatologist and Neonate feeding tolerance .
Intervention groups
1
Description
Intervention group: Oropharyngeal administration of 0.2 cc Colostrum was started at the first hour of life, It was given every 3 hour for 3 days.
Category
Treatment - Other
2
Description
Control group: Breast Milk Minimal Enteral Feeding administration was started after 72 hours of life.