Late Onset Neonatal SepsisNCT03926390
Gut Priming With Oral Bovine Colostrum for Preterm Neonates; Randomized Control Trial
A study testing Bovine colostrum in people with Late Onset Neonatal Sepsis and Necrotizing Enterocolitis of Newborn, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells. Read more about this study
- Who is it for?
- Ages 24 hours to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Feeding; Difficult, Newborn
- What is being tested?
- Bovine colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2018to 15 Sep 2019
- 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 24 hours to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Preterm Neonate having a gestational age equal or less than 34 weeks at birth, admitted in Ain-Shams University NICUs
Who cannot join
- • Maternal risk factor of early onset sepsis, chorioamnionitis.
- Proved early onset sepsis.
- Life-threatening congenital abnormalities.
- Inborn error of metabolism.
- Chromosomal aberrations.
- Neonates with underlying gastrointestinal problems (such as GIT anomalies) that prevent enteral feeding.
- Perinatal asphyxia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates
The aim was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells. And to evaluate the effect of bovine colostrum concentrate on feeding tolerance, growth, hospital stay and mortality in preterm neonates.
Read the detailed description
The study was interventional, double blinded and randomized trial ، performed on preterm neonates( <34 week) admitted on Ain ShamsUniversity (ASU) neonatal intensive care units (NICU) after considering exclusion criteria.
The enrolled patients was subdivided into two groups; group A are infants with non bovine colstrum and group B with bovine colostrum All infants received the standard neonatal care and underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.
- Data Collection: Careful history taking
- Antenatal history including: rupture of membrane, Chorioamnionitis, history of urinary tract infection.
- Natal history including: mode of delivery, place of delivery, the need for resuscitation, recorded Apgar score at 1minute and 5 minutes.
- Postnatal history including: age of admission in neonatal intensive care unit, symptoms suggest infection.
II. Thorough clinical assessment:
- Weight and Occiptofrontal circumference (twice weekly).
- Complete examination including cardiovascular, respiratory, abdominal and neurological examination.
III. Laboratory investigations:
- Complete blood picture, C-reactive protein on admission and repeated twice weekly
- Blood culture before starting treatment and with any suspected sepsis.
- In first 24 hours and the end of second week : Collecting peripheral blood mononuclear cells to be analyzed for cellular parameters by flow cytometry (CD4 T cells, CD25 L, FOXP3). Three subsets of CD4+ T cells will be defined according to CD25 staining: CD25- , CD25 low, and CD25 high. Cells expressing CD25 high will be chosen and gated for the detection of FOXP3+ T cells.
IV. Radiological investigations:
Chest X-ray (It was done on admission and repeated when needed). Abdominal X-ray (when necrotizing enterocolitis is suspected). Abdominal ultrasound (when necrotizing enterocolitis is suspected).
- Follow-up and end-point of the study:
All infant underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.NPO for more than 24 hours
The following primary outcome data was recorded:
- Clinical examination and laboratory investigations when clinically indicated for evidence of sepsis.
- Clinical examination and radiological investigations when clinically indicated for evidence of NEC.
A secondary outcome measure includes weight increment per kg per week, duration of hospitalization, mortality if any, monitoring adverse effects of treatment (if any); such as emesis, increased gastric residuals, increased abdominal girth, diarrhea, skin rash. Long term outcome includes necrotizing enterocolitis, and intracranial hemorrhage.
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Feeding; Difficult, Newborn
- Being tested
- Bovine colostrum
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine colostrumDietary supplement
bovine colostrum for first 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Non bovine colostrun | No intervention | Preterm received preterm formula |
| Bovine colostrum group | Active comparator | Preterm received bovine colostrum as trophic feeding Receives: Dietary Supplement: Bovine colostrum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Late Onset Sepsis in the three groups
Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system
Measured: From time of randomization to discharge from nicu or death whichever comes first
The incidence of Necrotizing Enterocolitis in the three groups
Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging
Measured: From time of randomization to discharge from nicu or death whichever comes first
The change of Active T regulatory cells In the three groups
Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3
Measured: Change from base line at randomization and after intervention by 1 week
Secondary outcomes (3)
Feeding intolerance is defined as presence of at least 3 consecutive days of any of the following:emesis, gastric residuals, diarrhea, blood in stools or abnormally enlarged bowel loops
Feeding intolerance
Measured: From time of randomization to discharge from nicu or death whichever comes first
Neonatal mortality
Number of deaths in the study group
Measured: From time of randomization to discharge from nicu or death whichever comes first
Duration of hospital stay
Duration of hospital stay
Measured: From time of randomization to discharge from nicu or death whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start15 Sep 2018
- Primary completion15 Jun 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Onset Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Ismail, Ain Shams University
- Investigators
- Hisham Awad, Principal investigator, professor of pediatrics Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926390
- Sponsor's protocol ID
- FMASU 50 / 2017
- Status last verified
- Jun 2020
- First submitted
- 8 Nov 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: research protocol
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates
- ClinicalTrials.gov ID
- NCT03926390
- Acronym / sponsor ID
- FMASU 50 / 2017
- Conditions
- Late Onset Neonatal Sepsis, Necrotizing Enterocolitis of Newborn, Feeding; Difficult, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 24 Apr 2019 (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 was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells. And to evaluate the effect of bovine colostrum concentrate on feeding tolerance, growth, hospital stay and mortality in preterm neonates.
Detailed description
The study was interventional, double blinded and randomized trial ، performed on preterm neonates( <34 week) admitted on Ain ShamsUniversity (ASU) neonatal intensive care units (NICU) after considering exclusion criteria.
The enrolled patients was subdivided into two groups; group A are infants with non bovine colstrum and group B with bovine colostrum All infants received the standard neonatal care and underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.
- Data Collection: Careful history taking
- Antenatal history including: rupture of membrane, Chorioamnionitis, history of urinary tract infection.
- Natal history including: mode of delivery, place of delivery, the need for resuscitation, recorded Apgar score at 1minute and 5 minutes.
- Postnatal history including: age of admission in neonatal intensive care unit, symptoms suggest infection.
II. Thorough clinical assessment:
- Weight and Occiptofrontal circumference (twice weekly).
- Complete examination including cardiovascular, respiratory, abdominal and neurological examination.
III. Laboratory investigations:
- Complete blood picture, C-reactive protein on admission and repeated twice weekly
- Blood culture before starting treatment and with any suspected sepsis.
- In first 24 hours and the end of second week : Collecting peripheral blood mononuclear cells to be analyzed for cellular parameters by flow cytometry (CD4 T cells, CD25 L, FOXP3). Three subsets of CD4+ T cells will be defined according to CD25 staining: CD25- , CD25 low, and CD25 high. Cells expressing CD25 high will be chosen and gated for the detection of FOXP3+ T cells.
IV. Radiological investigations:
Chest X-ray (It was done on admission and repeated when needed). Abdominal X-ray (when necrotizing enterocolitis is suspected). Abdominal ultrasound (when necrotizing enterocolitis is suspected).
- Follow-up and end-point of the study:
All infant underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.NPO for more than 24 hours
The following primary outcome data was recorded:
- Clinical examination and laboratory investigations when clinically indicated for evidence of sepsis.
- Clinical examination and radiological investigations when clinically indicated for evidence of NEC.
A secondary outcome measure includes weight increment per kg per week, duration of hospitalization, mortality if any, monitoring adverse effects of treatment (if any); such as emesis, increased gastric residuals, increased abdominal girth, diarrhea, skin rash. Long term outcome includes necrotizing enterocolitis, and intracranial hemorrhage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non bovine colostrun | No intervention | –Preterm received preterm formula |
| Bovine colostrum group | Active comparator | Dietary Supplement: Bovine colostrumPreterm received bovine colostrum as trophic feeding |
Who may qualify
- Ages
- 24 hours to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- • Preterm Neonate having a gestational age equal or less than 34 weeks at birth, admitted in Ain-Shams University NICUs
Key exclusion criteria (7 listed)
- • Maternal risk factor of early onset sepsis, chorioamnionitis.
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 |
|---|---|---|
| Bovine colostrumbovine colostrum for first 2 weeks | Dietary supplement | Bovine colostrum group |
Primary outcome
Incidence of Late Onset Sepsis in the three groups
Time frame: From time of randomization to discharge from nicu or death whichever comes first
Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system
The incidence of Necrotizing Enterocolitis in the three groups
Time frame: From time of randomization to discharge from nicu or death whichever comes first
Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging
The change of Active T regulatory cells In the three groups
Time frame: Change from base line at randomization and after intervention by 1 week
Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3
3 secondary outcomes
Feeding intolerance is defined as presence of at least 3 consecutive days of any of the following:emesis, gastric residuals, diarrhea, blood in stools or abnormally enlarged bowel loops
Time frame: From time of randomization to discharge from nicu or death whichever comes first
Neonatal mortality
Time frame: From time of randomization to discharge from nicu or death whichever comes first
Duration of hospital stay
Time frame: From time of randomization to discharge from nicu or death whichever comes first
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 23 Jun 2020.
- Individual participant dataSharing planned: No. research protocol
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Late-Onset Neonatal Sepsis, Extreme Prematurity
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Vancomycin Reduction Practices (VRP) in the NICU
Antibiotic Stewardship, Neonatal Sepsis, Late-Onset
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Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
Neonatal Late Onset Sepsis
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MDW as a Novel Diagnostic Biomarker in LONS Among Preterm Neonates
Late Onset Neonatal Sepsis
Not yet recruiting
Neonatal Catheter Lock for Infection Prevention
CLABSI - Central Line Associated Bloodstream Infection, CRBSI - Catheter Related Bloodstream Infection
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.
Hisham Awad principal investigator
professor of pediatrics Ain Shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine colostrum in people with Late Onset Neonatal Sepsis and Necrotizing Enterocolitis of Newborn, run by Ain Shams 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 1 inclusion and 7 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 23 Jun 2020. 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?
Incidence of Late Onset Sepsis in the three groups (time frame: From time of randomization to discharge from nicu or death whichever comes first). The study lists 3 primary outcomes in all. 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 23 Jun 2020.