Early Diagnosis
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Universidade Estadual de Feira de Santana (UEFS/BAHIA)