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

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/.