Preterm
Conditions
Keywords
Premature infants, colostrum, ROP
Brief summary
The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.
Detailed description
This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital. The study will be carried out in 4 phases: 1. First phase: Enrollment and selection phase. 2. Second phase: Intervention phase ( enteral bovine colostrum administration) . 3. Third phase: Evaluation phase. 4. Fourth phase: collected data analysis and results.
Interventions
DIETARY_SUPPLEMENTThe bovine colostrum ( trade name : baby steps sachets, 300mg )
The bovine colostrum sachets will be used in a dose of 3.5ml/kg/ day , starting from the first 3 days after birth, for 14 days. Enteral route, either through nasogastric tube or orally.
DIETARY_SUPPLEMENTPlacebo
distilled water with no bovine colostrum
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
Eligibility
Sex/Gender
ALL
Age
1 Hours to 3 Days
Healthy volunteers
No
Inclusion criteria
* Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fundus examination to detect retinopathy of prematurity | 28 days | ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prematurity related complications | 28 days | * late onset sepsis * IVH * Necrotizing enterocolitis * bronchopulmonary dysplasia |
| Assessment of weight | 28 days | -Assessment of weight every other day. |
| -Assessment of Head circumference | 28 days | measurement of Head circumference weekly. |
| -Assessment of length | 28 days | -Assessment of length on admission and on discharge. |
Countries
Egypt
Outcome results
None listed