PrematurityNCT06534632
Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants
A study testing Mother's colostrum in people with Prematurity, run by General Organization for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages 1 hour to 24 hours
- Conditions the study is for
- Prematurity
- What is being tested?
- Mother's colostrum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Nov 2023
- 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 hour to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very-low-birth-weight preterm newborns admitted to the neonatal intensive care unit within 24 hours after delivery
- Neonates with gestational age ≤ 34 weeks and weight ≤ 1500 grams
Who cannot join
- Infants with severe gastrointestinal malformations.
- Infants with serious congenital anomalies or chromosomal abnormalities.
- Infants with signs of early-onset sepsis.
- Any contraindications for breastfeeding because of maternal conditions including active tuberculosis or AIDS, or treatment with medications excreted in breast milk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants
This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.
Read the detailed description
The study was a randomized clinical trial, performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria.
The enrolled newborns were randomly subdivided into two groups (1:1). The colostrum group received their mother's colostrum, and the placebo group received placebo (sterile water) using a standardized protocol. The newborns received 0.2 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx (0.1 mL on either side of the oral cavity), starting during the first 24 hours of life and lasting for 5 days. Vital signs were carefully monitored throughout the procedure. Dosing was provided every 6 hours during the study period.
All infants underwent follow-up from birth until discharge or death whichever came first. Neonates were evaluated for occurrence of late-onset sepsis, death, and other clinical outcomes.
- Conditions
- Prematurity
- Being tested
- Mother's colostrum, Placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother's colostrumOther
Oropharyngeal administration of mother's colostrum
PlaceboOther
Oropharyngeal administration of sterile water
| Study group | Role | What they receive |
|---|---|---|
| Colostrum group | Experimental | The interventional group received their mother's colostrum through the oropharyngeal route beginning within the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours Receives: Other: Mother's colostrum |
| Placebo group | Placebo comparator | The placebo group received sterile water through the oropharyngeal route beginning in the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants with late-onset sepsis in each group
Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age
Measured: Up to 40 weeks corrected gestational age
Secondary outcomes (1)
Mortality
Number of deaths in each group
Measured: Up to 40 weeks corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Nov 2022
- Primary completion30 Oct 2023
- Study completion1 Nov 2023
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.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Organization for Teaching Hospitals and Institutes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Taha, MD, General Organization for Teaching Hospitals and Institutes
- Investigators
- Marwa Taha, M.D., Principal investigator, Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, EgyptMai M Mostafa, M.D., Study director, Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, EgyptFifi Helmy, M.D., Study director, Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, EgyptSohaila A Abd El-Halim, M.D., Study director, Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534632
- Sponsor's protocol ID
- HM000142
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 5 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants
- ClinicalTrials.gov ID
- NCT06534632
- Acronym / sponsor ID
- HM000142
- Conditions
- Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- General Organization for Teaching Hospitals and InstitutesUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 2 Aug 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.
This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.
Detailed description
The study was a randomized clinical trial, performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria.
The enrolled newborns were randomly subdivided into two groups (1:1). The colostrum group received their mother's colostrum, and the placebo group received placebo (sterile water) using a standardized protocol. The newborns received 0.2 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx (0.1 mL on either side of the oral cavity), starting during the first 24 hours of life and lasting for 5 days. Vital signs were carefully monitored throughout the procedure. Dosing was provided every 6 hours during the study period.
All infants underwent follow-up from birth until discharge or death whichever came first. Neonates were evaluated for occurrence of late-onset sepsis, death, and other clinical outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostrum group | Experimental | Other: Mother's colostrumThe interventional group received their mother's colostrum through the oropharyngeal route beginning within the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours |
| Placebo group | Placebo comparator | Other: PlaceboThe placebo group received sterile water through the oropharyngeal route beginning in the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours |
Who may qualify
- Ages
- 1 hour to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Very-low-birth-weight preterm newborns admitted to the neonatal intensive care unit within 24 hours after delivery
- Neonates with gestational age ≤ 34 weeks and weight ≤ 1500 grams
Key exclusion criteria (4 listed)
- Infants with severe gastrointestinal malformations.
- Infants with serious congenital anomalies or chromosomal abnormalities.
- Infants with signs of early-onset sepsis.
- Any contraindications for breastfeeding because of maternal conditions including active tuberculosis or AIDS, or treatment with medications excreted in breast milk.
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 |
|---|---|---|
| Mother's colostrumOropharyngeal administration of mother's colostrum | Other | Colostrum group |
| PlaceboOropharyngeal administration of sterile water | Other | Placebo group |
Primary outcome
Number of infants with late-onset sepsis in each group
Time frame: Up to 40 weeks corrected gestational age
Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age
1 secondary outcome
Mortality
Time frame: Up to 40 weeks corrected gestational age
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 5 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.
Marwa Taha, M.D. principal investigator
Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
Mai M Mostafa, M.D. study director
Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
Fifi Helmy, M.D. study director
Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother's colostrum in people with Prematurity, run by General Organization for Teaching Hospitals and Institutes 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 4 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 5 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. Some participants in this study may receive a placebo. 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?
Number of infants with late-onset sepsis in each group (time frame: Up to 40 weeks corrected gestational age). 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 5 Aug 2024.