Oropharyngeal Administration Of Colostrum For Preventing Necrotizing

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06459414
Study type	Interventional
Source	Cairo University
Contact	Hoda Atef Abelsattar Ibrahim
Phone	01116344417
Email	hodaibrahim424@gmail.com
Status	Recruiting
Phase	N/A
Start date	April 15, 2024
Completion date	July 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03670732` - CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure	N/A
Completed	`NCT05322161` - Yoga in the NICU for Parents Study	N/A
Recruiting	`NCT04542096` - Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
Recruiting	`NCT04911452` - Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants	N/A
Recruiting	`NCT02901652` - NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome	N/A
Completed	`NCT02148965` - Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial	N/A
Completed	`NCT02273843` - A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis	Phase 1
Terminated	`NCT02032511` - Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)	N/A
Completed	`NCT01721629` - Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants	N/A
Terminated	`NCT01819532` - Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks	N/A
Completed	`NCT01523769` - Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants	N/A
Completed	`NCT00951860` - Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort	N/A
Completed	`NCT01478711` - Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants	N/A
Completed	`NCT00749008` - Study of Generalized Movements for Early Prediction of Cerebral Palsy	N/A
Completed	`NCT00787124` - Transfusions and Nitric Oxide Level in Preterm Infants
Completed	`NCT00527956` - Facilitation and Barriers to Breastfeeding in the NICU	N/A
Terminated	`NCT01208493` - Dietary Protein in the Very-low-birth-weight Infant	N/A
Terminated	`NCT00486395` - Will CPAP Reduce Length Of Respiratory Support In Premature Infants?	Phase 3
Completed	`NCT03372590` - NEO Rehab for Infants at Risk of Cerebral Palsy	N/A
Completed	`NCT00033917` - Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms