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The use of mother's milk in newborns with gastroschisis

Colostrotherapy in newborns with gastroschisis: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3t3jvr
Enrollment
Unknown
Registered
2020-03-27
Start date
2019-03-31
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

Gastroschisis

Interventions

Experimental group: 22 newborns with gastroschisis who received colostrum from their mother, in the oral mucosa in the first 48 hours of life until 72 hours of life. Control group: 22 newborns with g
Other

Sponsors

Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira IFF/ Fiocruz
Lead Sponsor
Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira IFF/ Fiocruz
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Newborns; both genres; born with gastroschisis; born in the hospital of origin

Exclusion criteria

Exclusion criteria: Newborns with a maternal history of recent drug use (before hospitalization and delivery); infection with the human immunodeficiency virus (HIV); human T cell lymphotropic virus (HTLV); those who die in the first days of life before completing the oropharyngeal administration protocol; mothers are unable to remove the required volume of colostrum

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of colostrotherapy in days to reach oral feeding in newborns with gastroschisis.This intervention proposal will be made through a randomized clinical trial, where patients will be classified to receive either colostrum or placebo for a reason of 1: 1. Based on the specified precision requirements, a minimum sample size of 22 patients in each treatment groups will be needed.

Secondary

MeasureTime frame
Analyze the effect of colostrotherapy on zero-diet days.This intervention proposal will be made through a randomized clinical trial, where patients will be classified to receive either colostrum or placebo for a reason of 1: 1. Based on the specified precision requirements, a minimum sample size of 22 patients in each treatment groups will be needed.;Analyze the effect of colostrotherapy in days to start enteral feeding;Analyze the effect of colostrotherapy in days to achieve a full diet;Analyze the effect of colostrotherapy in days on parenteral nutrition;Analyze the effect of colostrotherapy in reducing sepsis;Analyze the effect of colostrotherapy on ? length of stay;Analyze the effect of colostrotherapy in days to start enteral feeding;Analyze the effect of colostrotherapy in days to achieve a full diet;Analyze the effect of colostrotherapy in days on parenteral nutrition;Analyze the effect of colostrotherapy in reducing sepsis

Countries

Brazil

Contacts

Public ContactHellen Pimenta

Instituto Nacional de Saúde da Mulher, da Criança e do Adolescente Fernandes Figueira IFF/ Fiocruz

hellen.pimenta@iff.fiocruz.br21 2554-1739

Outcome results

None listed

Source: REBEC (via WHO ICTRP)