Active — Not RecruitingNot Applicable

Probiotics and the Neurodevelopment in the Premature Infant <32 Weeks Gestational Age and <1500g

Spain233 participantsStarted 2014-01-01

Plain-language summary

Unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (Bifidobacterium bifidum NCDO 2203 and Lactobacillus acidophilus NCDO 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. This probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of NEC. The investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. Additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers. Secondarily, this mixture of probiotics could reduce NEC, LOS, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.

Who can participate

Age range

32 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Premature infants under 32 weeks gestational age and less than 1500g birthweight. * Born at BCNatal Hospital Clínic between years 2014-2019. Exclusion Criteria: * All neonates presenting with suspected congenital anomalies, inborn errors of metabolism, or genetic defects were excluded. * Infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 6 years of age

Timeframe: 6 years

Degree of neurodevelopment at 6 years of age

Timeframe: 6 years

Degree of neurodevelopment at 6 years of age

Timeframe: 6 years

Neuroplasticity biomarkers and intestinal permeability

Trial details

NCT IDNCT05945017

SponsorFundacion Clinic per a la Recerca Biomédica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-31

View on ClinicalTrials.gov More Infant, Newborn, Diseases trials

Plain-language summary

Who can participate

Age range

32 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 24 months corrected age

Timeframe: 24 months

Degree of neurodevelopment at 6 years of age

Timeframe: 6 years

Degree of neurodevelopment at 6 years of age

Timeframe: 6 years

Degree of neurodevelopment at 6 years of age

Timeframe: 6 years

Neuroplasticity biomarkers and intestinal permeability