Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hoda Atef Abdelsattar Ibrahim

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

: 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)

Other names: Oropharyngeal Administartion of Colostrum

Primary outcomes

The difference in hospital length of stay between preterm neonates who received colostrum for 3 days and those who did not receive it

Time frame: 2 month

Determination of possible protective effects of colostrum via assessing the hospital stay

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis and Late-onset Sepsis In Preterm Preterms

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jun 14, 2024
Registry last updated: Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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