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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: bovine colostrum group | Active Comparator |
| |
| group II : control group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The bovine colostrum ( trade name : baby steps sachets, 300mg ) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fundus examination to detect retinopathy of prematurity | ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| prematurity related complications |
| 28 days |
| Assessment of weight | -Assessment of weight every other day. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with any of the following will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Alaaaldin Thabet, PhD | Faculty of medicine, Alexandria University, Egypt | Study Director |
| Islam Shereen Hamdy, PhD | Faculty of medicine, Alexandria University, Egypt | Study Director |
| Eman Shabban Mohamed, MBBCh | Faculty of medicine, Alexandria University, Egypt | Principal Investigator |
| Marwa Mohamed Farag, PhD | Faculty of medicine, Alexandria University, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria university, Elshattbi hospital | Alexandria | 0354 | Egypt | |||
| Marwa Mohamed Farag |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39427215 | Derived | Farag MM, Thabet MAEH, Ahmed IS, Hanafi NF, Elsawy WS, Mohamed ES. Do preterm infants' retinas like bovine colostrum? A randomized controlled trial. Ital J Pediatr. 2024 Oct 19;50(1):218. doi: 10.1186/s13052-024-01781-z. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
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| Placebo | Dietary Supplement | distilled water with no bovine colostrum |
|
| 28 days |
| -Assessment of Head circumference | measurement of Head circumference weekly. | 28 days |
| -Assessment of length | -Assessment of length on admission and on discharge. | 28 days |
| Alexandria |
| 0356 |
| Egypt |
| D000091642 | Urogenital Diseases |