PretermNCT05438680
Bovine Colostrum in Prevention of Sepsis and Retinopathy of Prematurity
A study testing The bovine colostrum ( trade name : baby steps sachets, 300mg ) in people with Preterm, run by Alexandria University at 2 sites in Egypt.
Trial summary
The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay. Read more about this study
- Who is it for?
- Ages 1 hour to 3 days
- Conditions the study is for
- Preterm
- What is being tested?
- The bovine colostrum ( trade name : baby steps sachets, 300mg )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 20 Jun 2022to 1 Oct 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 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life
Who cannot join
- Patients with any of the following will be excluded:
- Obvious major congenital abnormalities.
- Infants expected to be >72 hours of age at the time of randomization.
- Parental consent lacking/refusal
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Alexandria university, Elshattbi hospital
Alexandria, 0354
Marwa Mohamed Farag
Alexandria, 0356
About this study
Official title: Evaluation of the Effect of Bovine Colostrum in Prevention of Late Onset Sepsis and Retinopathy of Prematurity
The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.
Read the detailed description
This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.
The study will be carried out in 4 phases:
- First phase: Enrollment and selection phase.
- Second phase: Intervention phase ( enteral bovine colostrum administration) .
- Third phase: Evaluation phase.
- Fourth phase: collected data analysis and results.
- Conditions
- Preterm
- Being tested
- The bovine colostrum ( trade name : baby steps sachets, 300mg ), Placebo
- Keywords
- Premature infants, colostrum, ROP
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The bovine colostrum ( trade name : baby steps sachets, 300mg )Dietary supplement
The bovine colostrum sachets will be used in a dose of 3.5ml/kg/ day , starting from the first 3 days after birth, for 14 days.
Enteral route, either through nasogastric tube or orally.
PlaceboDietary supplement
distilled water with no bovine colostrum
| Study group | Role | What they receive |
|---|---|---|
| Group I: bovine colostrum group | Active comparator | Not described Receives: Dietary Supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg ) |
| group II : control group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundus examination to detect retinopathy of prematurity
ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease
Measured: 28 days
Secondary outcomes (4)
prematurity related complications
- late onset sepsis
- IVH
- Necrotizing enterocolitis
- bronchopulmonary dysplasia
Measured: 28 days
Assessment of weight
-Assessment of weight every other day.
Measured: 28 days
-Assessment of Head circumference
measurement of Head circumference weekly.
Measured: 28 days
-Assessment of length
-Assessment of length on admission and on discharge.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start20 Jun 2022
- Primary completion20 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
- Investigators
- Mohamed Alaaaldin Thabet, PhD, Study director, Faculty of medicine, Alexandria University, EgyptIslam Shereen Hamdy, PhD, Study director, Faculty of medicine, Alexandria University, EgyptEman Shabban Mohamed, MBBCh, Principal investigator, Faculty of medicine, Alexandria University, EgyptMarwa Mohamed Farag, PhD, Study chair, Faculty of medicine, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438680
- Sponsor's protocol ID
- 0106797
- Status last verified
- Oct 2023
- First submitted
- 13 Jun 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farag MM, Thabet MAEH, Ahmed IS, Hanafi NF, Elsawy WS, Mohamed ES. Do preterm infants' retinas like bovine colostrum? A randomized controlled trial. Ital J Pediatr. 2024 Oct 19;50(1):218. doi: 10.1186/s13052-024-01781-z.
PubMed 39427215
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Bovine Colostrum in Prevention of Late Onset Sepsis and Retinopathy of Prematurity
- ClinicalTrials.gov ID
- NCT05438680
- Acronym / sponsor ID
- 0106797
- Conditions
- Preterm
- Keywords
- Premature infants, colostrum, ROP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 30 Jun 2022 (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.
The aim of this study is to evaluate efficacy of bovine colostrum administration as a prophylaxis to decrease the incidence and the occurrence of retinopathy of prematurity in preterm neonates of gestational age less than 32 weeks during their hospital stay.
Detailed description
This study will include a randomized controlled trial carried out on preterm neonates who will fulfill the eligibility criteria delivered at Alexandria University Children's Hospital. Evaluation of the outcome will be done only for those who admitted to the neonatal intensive care unit (NICU) at Alexandria University Children's Hospital.
The study will be carried out in 4 phases:
- First phase: Enrollment and selection phase.
- Second phase: Intervention phase ( enteral bovine colostrum administration) .
- Third phase: Evaluation phase.
- Fourth phase: collected data analysis and results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Masking controlled clinical trial will be used to assess the effect of prophylactic bovine colostrum in preventing retinopathy of prematurity.
| Arm | Type | Receives |
|---|---|---|
| Group I: bovine colostrum group | Active comparator | Dietary Supplement: The bovine colostrum ( trade name : baby steps sachets, 300mg ) |
| group II : control group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 1 hour to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants ≤ 32 weeks gestational age, weight ≤ 1500 gm. Start feeding in the first 72 hours of life
Key exclusion criteria (4 listed)
- Obvious major congenital abnormalities.
- Infants expected to be >72 hours of age at the time of randomization.
- Parental consent lacking/refusal
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 |
|---|---|---|
| The bovine colostrum ( trade name : baby steps sachets, 300mg )The bovine colostrum sachets will be used in a dose of 3.5ml/kg/ day , starting from the first 3 days after birth, for 14 days. Enteral route, either through nasogastric tube or orally. | Dietary supplement | Group I: bovine colostrum group |
| Placebodistilled water with no bovine colostrum | Dietary supplement | group II : control group |
Primary outcome
Fundus examination to detect retinopathy of prematurity
Time frame: 28 days
ROP screen will be performed by ophthalmologist to detect zone stage extension and severity of the disease
4 secondary outcomes
prematurity related complications
Time frame: 28 days
Assessment of weight
Time frame: 28 days
-Assessment of Head circumference
Time frame: 28 days
-Assessment of length
Time frame: 28 days
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 12 Oct 2023.
- Derived from this study: PubMed 39427215Farag MM, Thabet MAEH, Ahmed IS, Hanafi NF, Elsawy WS, Mohamed ES. Do preterm infants' retinas like bovine colostrum? A randomized controlled trial. Ital J Pediatr. 2024 Oct 19;50(1):218. doi: 10.1186/s13052-024-01781-z.
- Individual participant dataSharing planned: No
Related trials for Preterm
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Mohamed Alaaaldin Thabet, PhD study director
Faculty of medicine, Alexandria University, Egypt
Islam Shereen Hamdy, PhD study director
Faculty of medicine, Alexandria University, Egypt
Eman Shabban Mohamed, MBBCh principal investigator
Faculty of medicine, Alexandria University, Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The bovine colostrum ( trade name : baby steps sachets, 300mg ) in people with Preterm, run by Alexandria University at 2 sites 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 1 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 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Fundus examination to detect retinopathy of prematurity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05438680, which also lists 1 linked publication.
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 12 Oct 2023.