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Evaluation of the use of human milk in the growth and development of very low birth weight premature infants

Impact of nutritional therapy with pasteurized colostrum/hypercaloric human milk on perinatal outcomes of very low birth weight preterm infants: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10pzjmbj
Enrollment
Unknown
Registered
2024-12-02
Start date
2024-12-17
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

Low birth weight for gestational age newborn

Interventions

This is a randomized, controlled, double-blind clinical study with very low birth weight newborns and their mothers enrolled up to 48 hours postpartum. Experimental group: 63 neonates receiving nutrit
A12.200.467

Sponsors

Departamento de Nutrição da Universidade Federal do Rio Grande do Norte
Lead Sponsor
Universidade Federal do Rio Grande do Norte
Collaborator

Eligibility

Age
No minimum to 7 Days

Inclusion criteria

Inclusion criteria: Very low birth weight newborns (VLBN) of both sexes; on an enteral diet by orogastric tube, with mother's own expressed breast milk (LMO) and pasteurized human milk (LHP) from the milk bank

Exclusion criteria

Exclusion criteria: Neonates diagnosed with severe congenital malformations; with congenital errors of metabolism; with chromosomal disorders; with birth weight < 700 g; with gestational age at birth < 23 weeks; neonates prescribed a colostrum diet, high-calorie, transitional or mature LHP; in use of human milk additive

Design outcomes

Primary

MeasureTime frame
To evaluate the velocity of weight gain in the newborn, measured from the difference in weight-for-age Z-score from birth to discharge from the ICU.—

Secondary

MeasureTime frame
It is expected to find a shorter birth weight recovery time (in days).;Assess the presence of extrauterine growth restriction, assessed according to weight-for-age z-score and length-for-age z-score.;Evaluate the adequacy of nutritional therapy, according to the time of full diet (100 to 120 kcal/kg/day), volume and nutritional adequacy of calories, proteins and fats according to weight and postnatal age.;Expect to find a shorter length of stay in the NICU and hospital (days).;It is expected to find fewer cases of pulmonary bronchodysplasia, retinopathy of prematurity, and metabolic bone disease of prematurity, diagnosed according to data on alkaline phosphatase dosage.—

Countries

Brazil

Contacts

Public ContactKarla Ribeiro Rodrigues

Universidade Federal do Rio Grande do Norte

karla.danielly@ufrn.br+55 (84) 991277204

Outcome results

None listed

Source: REBEC (via WHO ICTRP)