PrematurityNCT06459414
Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis in Preterrms
A study testing : Oropharyngeal Administration Of Colostrum in people with Prematurity, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 day to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- : Oropharyngeal Administration Of Colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2024to 17 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis and Late-onset Sepsis In Preterm Preterms
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.
Read the detailed 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.
- Conditions
- Prematurity
- Being tested
- : Oropharyngeal Administration Of Colostrum
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: Oropharyngeal Administration Of ColostrumOther
Also called Oropharyngeal Administartion of Colostrum
Preterm less than 34 weeks gestation will receive Oropharyngeal Colostrum for 3 days ( the first group) and for 10 days( the second group)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: : Oropharyngeal Administration Of Colostrum |
| 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 Receives: Other: : Oropharyngeal Administration Of Colostrum |
| Control group recieving only the standard care | No intervention | The control group will receive only the standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start15 Apr 2024
- Primary completion29 Jul 2024
- Study completion17 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Atef Abdelsattar Ibrahim, Cairo University
- Investigators
- Iman Eiada, Principal investigator, Professor of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459414
- Sponsor's protocol ID
- MS-615-2022
- Status last verified
- Aug 2024
- First submitted
- 29 Apr 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oropharyngeal Administration Of Colostrum For Preventing Necrotizing Enterocolitis and Late-onset Sepsis In Preterm Preterms
- ClinicalTrials.gov ID
- NCT06459414
- Acronym / sponsor ID
- MS-615-2022
- Conditions
- Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 17 Aug 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interventional group recieveing Oropharyngeal Of Colostrum for 3 days | Experimental | Other: : Oropharyngeal Administration Of ColostrumThe 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 | Other: : Oropharyngeal Administration Of ColostrumThe 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 |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| : Oropharyngeal Administration Of ColostrumAlso: Oropharyngeal Administartion of ColostrumPreterm less than 34 weeks gestation will receive Oropharyngeal Colostrum for 3 days ( the first group) and for 10 days( the second group) | Other | Interventional group recieveing Oropharyngeal Of Colostrum for 10 days, Interventional group recieveing Oropharyngeal Of Colostrum for 3 days |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iman Eiada principal investigator
Professor of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing : Oropharyngeal Administration Of Colostrum in people with Prematurity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.