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01-12-2020 | Study protocol

Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study

Authors: Camilla da Cruz Martins, Michelle de Santana Xavier Ramos, Mara Viana Cardoso Amaral, Jéssica Santos Passos Costa, Ellayne Souza Cerqueira, Tatiana de Oliveira Vieira, Simone Seixas dA Cruz, Graciete Oliveira Vieira

Published in: BMC Pediatrics | Issue 1/2020

Abstract

Background

The oropharyngeal colostrum administration protocol to treat premature newborns is a possible and plausible strategy in neonatal health services, since the immunoprotective components of colostrum can be absorbed by the lymphoid tissues of the oropharynx. In this context, this study aims to describe the implementation of oropharyngeal colostrum immunotherapy in very low birth weight preterm newborns in a neonatal unit, as well as to test an algorithm in a public hospital.

Methods

The protocol is applied in a non-randomized, superiority clinical trial with historical control. In the treatment group, 0.2 mL of raw colostrum is dripped into the right and left oropharyngeal mucosa, totaling 8 administrations every 24 h until the 7th complete day of life interruptedly. The control group consists of very low birth weight preterm newborns born in the same hospital in previous years (historical control). The clinical progression of 60 newborns until hospital discharge is recorded on standardized forms. A total of 350 participants are estimated to complete the survey in 4 years. The occurrence of continuous outcomes between the groups are compared through the paired t-test or Wilcoxon’s two-sample test. The chi-square test or Fisher’s exact test, and survival analysis are used for binary outcomes. The nutritional status is assessed through Intergrowth-21st growth curves for preterm newborns.

Discussion

The flows of the protocol’s actions is sorted by an algorithm, compatible with the Brazilian reality of a public hospital. This measure facilitates and systematizes clinical care, organizes the team’s work process, speeds up the intervention steps, standardizes decision-making and unifies the quality of care, besides showing the feasibility of oropharyngeal colostrum immunotherapy.

Trial registration

ReBEC, U1111–1222-0598, Registered 09 October 2018, http://www.ensaiosclinicos.gov.br/rg/RBR-2cyp7c/.

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Title: Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study
Authors: Camilla da Cruz Martins
Michelle de Santana Xavier Ramos
Mara Viana Cardoso Amaral
Jéssica Santos Passos Costa
Ellayne Souza Cerqueira
Tatiana de Oliveira Vieira
Simone Seixas dA Cruz
Graciete Oliveira Vieira
Publication date: 01-12-2020
Publisher: BioMed Central
Published in: BMC Pediatrics / Issue 1/2020
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-020-02266-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Colostrum oropharyngeal immunotherapy for very low birth weight preterm infants: protocol of an intervention study

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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