Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

Cairo University (CU)

Status: Completed

Conditions: Prematurity

Treatments: Other: : Oropharyngeal Administration Of Colostrum

Study type: Interventional

Funder types: Other

Identifiers

NCT06459414

MS-615-2022

Details and patient eligibility

About

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.

Full description

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, .

• Group A: receiving oropharyngeal colostrum for 10 days.
• Group B: control group receiving placebo for 10 days.
• Group C: receiving oropharyngeal colostrum for 3 days.

Enrollment: 96 patients

Sex: All

Ages: 1 to 2 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Neonates with gestational age (GA) ≤ 34 weeks at birth
• Neonates who will be in admitted in the neonatal intensive care unit (NICU) within 48 hours after birth.

Exclusion criteria

• Any contraindication for breastfeeding as mother-related (e.g. Mothers prohibited from breastfeeding because of conditions including active tuberculosis or AIDS, treatment with radioisotopes (e.g., Iodine-131, Cobalt-60, Cesium-137) and substance abuse)
• Also any contraindication for breastfeeding as infant-related (Birth complicated with severe gastrointestinal malformations).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

96 participants in 3 patient groups

Interventional group recieveing Oropharyngeal Of Colostrum for 3 days

Experimental group

Description:

The first interventional group will receive colostrum of their mother's breast milk through oropharyngeal route for 3 days on 1 ml/kg/day

Treatment:

Other: : Oropharyngeal Administration Of Colostrum

Interventional group recieveing Oropharyngeal Of Colostrum for 10 days

Experimental group

Description:

The second interventional group will receive colostrum of their mother's breast milk through oropharyngeal route for 10 days on 1 ml/kg/day

Treatment:

Other: : Oropharyngeal Administration Of Colostrum

Control group recieving only the standard care

No Intervention group

Description:

The control group will receive only the standard care