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Assessment of brain development in preterm infants who received Maternal Colostrum at birth

Assessment of Developmental in preterm infants exposed to Oropharyngeal Colostrum Immunotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-86n2z67
Enrollment
Unknown
Registered
2025-08-05
Start date
2024-05-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Diagnosis

Interventions

This is a prospective cohort nested within an analytical non-randomized superiority clinical trial with newborns with gestational age under 37 weeks preterm newborns with very low birth weight very lo

Sponsors

Universidade Estadual de Feira de Santana (UEFS/BAHIA)
Lead Sponsor

Eligibility

Age
72 Hours to 1 Years

Inclusion criteria

Inclusion criteria: Preterm newborns; with gestational age less than 37 weeks; weight below 1,500 grams; for the exposure group, only those on zero, enteral, or parenteral feeding; and clinically stable in the past three hours

Exclusion criteria

Exclusion criteria: Newborns whose mothers have a diagnosis of psychological disorders; triplet or higher-order multiple pregnancies; newborns with syndromes or congenital malformations; mothers with contraindications to breastfeeding; as well as newborns receiving vasopressor medication at doses higher than 10 mcg·kg?¹·min?¹ or requiring immediate surgical intervention

Design outcomes

Primary

MeasureTime frame
A minimum score of 26 points in the neurological assessment in the exposed group and a 2-point higher variation in the score compared to the group not exposed to Oropharyngeal Colostrum Immunotherapy, as assessed by the Hammersmith Neonatal Neurological Examination. No concerns or developmental delays in the exposed group when assessed using the Denver II Test, at the ages and time points described in the method

Secondary

MeasureTime frame
No secondary outcomes are expected

Countries

Brazil

Contacts

Public ContactGleice Cordeiro

Universidade Estadual de Feira de Santana (UEFS/BAHIA)

gocordeiro@uefs.br+55(074)991108034

Outcome results

None listed

Source: REBEC (via WHO ICTRP)