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Mother's milk samples will be collected during the routine expression of milk, using a hospital-grade electric breast pump, and will be stored in the NICU breastmilk refrigerator. The research doctor will prepare the syringes for the first 24 hours of the Initial Treatment Period. For neonates in the placebo group, the milk is immediately frozen, in a separate NICU breastmilk freezer to maintain blinding, for later use when enteral feedings are started. Using sterile gloves, oral syringes will be each filled with 1 mL/kg of colostrum or normal saline 0.9% (based on group assignment), capped, and covered with a white tape as a blinding procedure. Each syringe will be labeled with the patient's name, medical record number, and the date and time of preparation. Syringes will be prepared in the same sterile manner, by the research doctor, every 24 hours.
Oropharyngeal administration procedure using a standardized protocol, the doctor will provide the dosing as follows: two syringes will be warmed to room temperature. The first syringe's cap is removed and the tip of the syringe is gently placed into the neonate's mouth, alongside the right buccal mucosal tissue. The syringe tip is directed posteriorly towards the oropharynx, and the total volume (0.5 mL/kg) is slowly administered, over 20 seconds. The second syringe will be placed in the neonate's mouth in the same manner, but alongside the left buccal mucosal tissue. The entire volume (0.5 mL/kg) is administered slowly, over 20 seconds. A petite swab is used to carefully swab the right buccal mucosal tissue, followed by the left buccal mucosal tissue (≤5 seconds each side). A total volume of 1 mL/kg is administered per treatment, with buccal swabbing taking place over 10 seconds. Vital signs are carefully monitored throughout the procedure. Dosing is provided every 3 hours during the period of study.
Sample size will be 34 in each group, .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group recieveing Oropharyngeal Of Colostrum for 3 days | Experimental | The first interventional group will receive colostrum of their mother's breast milk through oropharyngeal route for 3 days on 1 ml/kg/day |
|
| Interventional group recieveing Oropharyngeal Of Colostrum for 10 days | Experimental | The second interventional group will receive colostrum of their mother's breast milk through oropharyngeal route for 10 days on 1 ml/kg/day |
|
| Control group recieving only the standard care | No Intervention | The control group will receive only the standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| : Oropharyngeal Administration Of Colostrum | Other | Preterm less than 34 weeks gestation will receive Oropharyngeal Colostrum for 3 days ( the first group) and for 10 days( the second group) |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in hospital length of stay between preterm neonates who received colostrum for 3 days and those who did not receive it | Determination of possible protective effects of colostrum via assessing the hospital stay | 2 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iman Eiada | Professor of Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoda Atef Abdelsattar Ibrahim | Cairo | Egypt |
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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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| D000091642 | Urogenital Diseases |