Premature InfantsNCT06501404
PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis
A study testing High dose group and Low dose group in people with Premature Infants and Necrotizing Enterocolitis, run by José Antonio Hurtado Suazo at 1 site in Spain.
Trial summary
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing… Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Premature Infants, Necrotizing Enterocolitis
- What is being tested?
- High dose group and Low dose group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2015to 20 Mar 2020
- 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 Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
- Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.
Who cannot join
- Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
- Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
- Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.
- Conditions
- Premature Infants, Necrotizing Enterocolitis
- Being tested
- High dose group, Low dose group
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose groupDietary supplement
A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains
Low dose groupDietary supplement
A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains
| Study group | Role | What they receive |
|---|---|---|
| High dose of probiotic mixture | Experimental | A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains Receives: Dietary Supplement: High dose group |
| Low dose of probiotic mixture | Experimental | A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains Receives: Dietary Supplement: Low dose group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of necrotizing enterocolitis and all-cause mortality
The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.
Measured: From birth until three months
Secondary outcomes (8)
Intestinal colonization by administered strains
Measured: From birth until three months
Incidence of Late Onset Sepsis
Incidence of Late Onset Sepsis. In accordance with the criteria used by the Castrillo Group for neonatal infections in Spain (compatible clinical symptoms, elevation of water-phase reactants and positive blood culture)
Measured: From birth until three months
Time to complete enteral nutrition
Time to reach complete enteral nutrition 140 ml/kg/day
Measured: From birth until three months
Days of Central Vascular Catheter
Measured: From birth until three months
Length of hospital stay
Days of hospital stay
Measured: From birth until three months
Weight change
Measured: From birth until three months
Incidence of Bronchopulmonary Dysplasia
Measured: From birth until three months
Incidence of patent ductus arteriosus
Measured: From birth until three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start10 Jan 2015
- Primary completion15 Jan 2015
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantsStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- José Antonio Hurtado Suazo
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Hospital Regional de Malaga, Hospital of Jaen, Hospital Costa del Sol, Hospital Universitario Torrecárdenas, Hospital Universitario Virgen Macarena, Complejo Hospitalario de Especialidades Juan Ramón Jimenez, Hospital Universitario de Valme, Hospitales Universitarios Virgen del Rocío, Hospital Universitario Puerta del Mar, Hospital General Universitario Santa Lucia, Hospital del SAS de Jerez
- Responsible party
- Sponsor-investigator, José Antonio Hurtado Suazo, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501404
- Sponsor's protocol ID
- PN01
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant
- ClinicalTrials.gov ID
- NCT06501404
- Acronym / sponsor ID
- PN01
- Conditions
- Premature Infants, Necrotizing Enterocolitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- José Antonio Hurtado SuazoUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Hospital Regional de Malaga, Hospital of Jaen, Hospital Costa del Sol, Hospital Universitario Torrecárdenas, Hospital Universitario Virgen Macarena, Complejo Hospitalario de Especialidades Juan Ramón Jimenez, Hospital Universitario de Valme, Hospitales Universitarios Virgen del Rocío, Hospital Universitario Puerta del Mar, Hospital General Universitario Santa Lucia, Hospital del SAS de Jerez
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 15 Jan 2015 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 15 Jul 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.
The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.
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 |
|---|---|---|
| High dose of probiotic mixture | Experimental | Dietary Supplement: High dose groupA daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains |
| Low dose of probiotic mixture | Experimental | Dietary Supplement: Low dose groupA daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.
- Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.
Key exclusion criteria (3 listed)
- Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.
- Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.
- Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.
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 |
|---|---|---|
| High dose groupA daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains | Dietary supplement | High dose of probiotic mixture |
| Low dose groupA daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains | Dietary supplement | Low dose of probiotic mixture |
Primary outcome
Incidence of necrotizing enterocolitis and all-cause mortality
Time frame: From birth until three months
The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.
8 secondary outcomes
Intestinal colonization by administered strains
Time frame: From birth until three months
Incidence of Late Onset Sepsis
Time frame: From birth until three months
Time to complete enteral nutrition
Time frame: From birth until three months
Days of Central Vascular Catheter
Time frame: From birth until three months
Length of hospital stay
Time frame: From birth until three months
Weight change
Time frame: From birth until three months
Incidence of Bronchopulmonary Dysplasia
Time frame: From birth until three months
Incidence of patent ductus arteriosus
Time frame: From birth until three months
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 15 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose group and Low dose group in people with Premature Infants and Necrotizing Enterocolitis, run by José Antonio Hurtado Suazo at 1 site in Spain.
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 3 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 15 Jul 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 Spain. 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 necrotizing enterocolitis and all-cause mortality (time frame: From birth until three months). 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 15 Jul 2024.