Premature Birth of NewbornPRECOLNCT02502916
Enteral Feeding and Early Gut Colonization of Preterm Infants
An observational study of Premature Birth of Newborn, run by Universidad Complutense de Madrid.
Trial summary
The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota. Read more about this study
- Who is it for?
- Ages 2 to 8 hoursHealthy volunteers can take part
- Conditions the study is for
- Premature Birth of Newborn
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jul 2012
- Phase
- Observational
- 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 2 to 8 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infants born from October 2009 to June 2010 at the Hospital 12 de Octubre with a gestational age of less than 32 weeks or with birth weight of less than 1,200 g
Who may be able to join
- gestational age of less than 32 weeks or with birth weight of less than 1,200 g
Who cannot join
- any malformation or suffering from any genetic metabolic disorder
About this study
Official title: Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants
The aim of this study is to evaluate the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.
Read the detailed description
First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit.
To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.
Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.
- Conditions
- Premature Birth of Newborn
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infant | Preterm infants born from October 2009 to June 2010 at a gestational age of less than 32 weeks or with birth weight of less than 1,200 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infants sharing bacterial strains with the milk received by each one
The meconium and fecal samples of the infants have been analysed microbiologically. In parallel, own's mother milk, donor milk and formula milk have been analyzed microbiologically after their pass through the nasogastric feeding tube. The bacterial strains isolated from fecal samples of each infant have been compared with the bacterial strains isolated from the milk that have received each of them.
Measured: two years
Secondary outcomes (1)
Number of bacterial strains shared by each infant and the milk received.
In each infant the number of the same bacterial strains isolated from fecal samples and milk received have been determined.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startOct 2009
- Primary completionJun 2010
- Study completionJul 2012
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 Premature Birth of NewbornStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan M. Rodríguez, Universidad Complutense de Madrid
- Investigators
- Juan M Rodriguez, PhD, Principal investigator, Universidad Complutense Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502916
- Sponsor's protocol ID
- PROBILAC/12O_2
- Acronym
- PRECOL
- Status last verified
- Jul 2015
- First submitted
- 12 Jul 2015
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gomez M, Moles L, Melgar A, Ureta N, Bustos G, Fernandez L, Rodriguez JM, Jimenez E. Early Gut Colonization of Preterm Infants: Effect of Enteral Feeding Tubes. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):893-900. doi: 10.1097/MPG.0000000000001104.
PubMed 26741949
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of the Enteral Feeding Systems on Early Bacterial Gut Colonization of Preterm Infants
- ClinicalTrials.gov ID
- NCT02502916
- Acronym / sponsor ID
- PRECOL / PROBILAC/12O_2
- Conditions
- Premature Birth of Newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Jul 2015 (estimated)
- 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 the potential role of the enteral feeding systems on the bacterial colonization of premature infants during their NICU admittance and its evolution after 2 years, which is the age when the infant's gut starts to contain an adult-like microbiota.
Detailed description
First spontaneously evacuated meconium and fecal samples were collected by the medical staff of the Hospital weekly from the diapers of the infants during their stay at the Neonatal Intensive Care Unit.
To evaluate the potential role of the enteral feeding systems as a site for colonization by nosocomial bacteria, and, its impact on early gut colonization of preterm neonates, mother's own milk, donor milk and preterm formula samples were obtained after passing through the external part of the enteral feeding tubes and cultured.
Later, when the infants reached 2 years of age, parents were contacted by phone to provide an additional fecal sample if their infants had not taken antibiotics within the previous 2 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infant | – | –Preterm infants born from October 2009 to June 2010 at a gestational age of less than 32 weeks or with birth weight of less than 1,200 g |
Who may qualify
- Ages
- 2 to 8 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants born from October 2009 to June 2010 at the Hospital 12 de Octubre with a gestational age of less than 32 weeks or with birth weight of less than 1,200 g
Key inclusion criteria (1 listed)
- gestational age of less than 32 weeks or with birth weight of less than 1,200 g
Key exclusion criteria (1 listed)
- any malformation or suffering from any genetic metabolic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of infants sharing bacterial strains with the milk received by each one
Time frame: two years
The meconium and fecal samples of the infants have been analysed microbiologically. In parallel, own's mother milk, donor milk and formula milk have been analyzed microbiologically after their pass through the nasogastric feeding tube. The bacterial strains isolated from fecal samples of each infant have been compared with the bacterial strains isolated from the milk that have received each of them.
1 secondary outcome
Number of bacterial strains shared by each infant and the milk received.
Time frame: two years
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 20 Jul 2015.
- Derived from this study: PubMed 26741949Gomez M, Moles L, Melgar A, Ureta N, Bustos G, Fernandez L, Rodriguez JM, Jimenez E. Early Gut Colonization of Preterm Infants: Effect of Enteral Feeding Tubes. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):893-900. doi: 10.1097/MPG.0000000000001104.
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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.
Juan M Rodriguez, PhD principal investigator
Universidad Complutense Madrid
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth of Newborn, run by Universidad Complutense de Madrid.
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 1 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 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of infants sharing bacterial strains with the milk received by each one (time frame: two years). 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 NCT02502916, 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 20 Jul 2015.