Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development (FEEDMI)
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|ClinicalTrials.gov Identifier: NCT03663556|
Recruitment Status : Unknown
Verified August 2018 by Universidade do Porto.
Recruitment status was: Recruiting
First Posted : September 10, 2018
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment|
|Very Preterm Infants||Other: Infant-feeding|
Meconium and the additional 3 fecal samples will be collected from preterm infants by the nursing team of MAC Neonatology Unit. Fecal samples will be collected every 7 days, during 21 days, from diapers into sterile tubes. Mothers will be asked to collect their own fecal samples with an appropriate stool collection kit (EasySampler®) and will be invited to complete a semi-quantitative food frequency questionnaire, previously validated for the Portuguese population.
Infant-feeding profile (breast milk, donor human milk or formula) of preterm infants will be recorded every day to select the most representative (>50 %) type of infant-feeding received during the 7 days prior to each fecal sample collection.
Additionally, detailed clinical data will be collected during the preterm infant enrollment in the study. Personal clinical data includes sociodemographic information and clinical intrapartum and postpartum outcomes, such as newborn's weight, days of antibiotic exposure, number of total days of hospitalization and others outcomes related to the preterm clinical evolution.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development|
|Actual Study Start Date :||May 25, 2017|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Very Preterm Infants
Newborn infants with less than 32 weeks admitted in the NICU.
Preterm infants hospitalized in the NICU can be feed by three different types of infant feeding, such as breast milk, donor human milk and/or formulas.
- Changes from baseline intestinal microbiota composition of preterm infants at 7, 14 and 21 days. [ Time Frame: The first fecal sample (meconium) of preterm infants will be collected. Afterwards, fecal samples will be collected every 7 days, during 21 days. ]The intestinal microbiota profile of preterm infants will be evaluated over time.
- Changes from baseline intestinal microbiota composition of preterm infants in relation to infant-feeding profile (breast milk, donor human milk or formula) at 7,14 and 21 days. [ Time Frame: Infant-feeding type of preterm infants before the first, second, third and fourth collection will be recorded during these 21 days. ]Infant-feeding profile (breast milk, donor human milk or formula) will be recorded every day to select the most representative type of infant-feeding (> 50 %) received during the 7 days prior to each fecal sample collection.
- Maternal intestinal microbiota composition, analyzed by RT-PCR. [ Time Frame: Maternal fecal samples will be collected after delivery up to 1 week. ]Mother's will be asked to collect their own fecal samples for gut microbiota analysis by RT-PCR. An appropriate stool collection kit will be provided (EasySampler Stool Collection kit).
- Changes in maternal gut microbiota in relation to clinical variables described below [ Time Frame: Clinical variables will be collected daily, until study completion an average of 2 years. ]Changes in intestinal microbiota profile of preterm infants' mothers will be evaluated in relation to mode of delivery, mother's gestational age, dietary pattern during pregnancy, weight gain in gestation and antibiotic exposure.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663556
|Contact: Sara Brito, MD||+351 firstname.lastname@example.org|
|Contact: Conceição Calhau, PhD||+351 218 803 email@example.com|
|Maternidade Dr. Alfredo da Costa, Centro Hospitalar de Lisboa Central||Recruiting|
|Lisbon, Portugal, 1050-010|
|Contact: Sara Brito, MD +351 964 278 547 firstname.lastname@example.org;|
|Contact: Juliana Morais, BsC +351 362711106 email@example.com|
|Principal Investigator: Sara Brito, MD|
|Sub-Investigator: Manuela Cardoso, BsC|
|Sub-Investigator: Teresa Tomé, MD|
|Sub-Investigator: Israel Macedo, MD|
|NOVA Medical School, Universidade Nova de Lisboa||Active, not recruiting|
|Lisbon, Portugal, 1169-056|