DISCUSSION
milk, Oropharyngeal, late-onset infection, preterm NB, early-onset, necrotizing, death, gastroschisis, infections, intestinal dysmotility, Dysmotility, oropharyngeal, coronavirus disease 2019, vomiting, abdominal distension, intestinal dysfunction, human milk or hydrolyzed formula, NB, malformations, breast milk
PRETERM BIRTH, NECROTIZING ENTEROCOLITIS, CORONAVIRUS DISEASE 2019, GASTROSCHISIS, ENTEROCOLITIS, DYSMOTILITY, INFECTIONS, SYNDROMES, EVENTS
Oropharyngeal administration of breast milk has been proposed as a viable alternative
to stimulate the immature neonatal immune system and provide protection against
infections.Limited scientific evidence suggests that oropharyngeal colostrum administration,
started within the first 48 hours of life, does not reduce the risk of necrotizing
enterocolitis, late-onset infection or death in very small and very low birth weight
infants.However, there is an investigation in the study by Ouyang et al.The lack of robust evidence to support this practice is limited by the lack of
studies with adequate power to evaluate the effects of this intervention on
clinically relevant outcomes, especially reducing the incidence of early-onset or
late-onset infection and necrotizing enterocolitis, which compromises neonatal
outcomes.This study is a randomized, double-blind, controlled clinical trial by a “sham
procedure”, which showed that there were no significant differences between the two
groups regarding oropharyngeal colostrum administration in relation to baseline
characteristics and clinical outcomes.Other published studies show differences regarding dosages, frequency of
administration, duration of intervention, type of milk, benefit population (weight
and gestational age); some studies even included oropharyngeal colostrum as part of
a feeding protocol, hindering the standardization and applicability of
findings.Studies with preterm infants observed good clinical results, favorable to the
colostrum group, regarding the decrease in the time required to obtain complete
enteral feeding, but there was no reduction in the length of hospital stay. This
result is similar to that found in the study by Seigel et al.,The studies that propose the oropharyngeal administration of colostrum in the
neonatal hospital context involve NBs with preterm births and are not yet being
performed in NBs with syndromes or malformations such as gastroschisis.Based on this premise and the scarcity of studies on the use of colostrum therapy in
NB patients with gastroschisis, this protocol was elaborated, constituting an
important stage in the accomplishment of the research, allowing a new result and
decision-making regarding the therapy. After the development and execution of this
document, no difficulties were observed in conducting the study, as suggested in
other studies.In our study, the colostrum therapy protocol for gastroschisis was initiated between
48 and 72 hours after birth, with good tolerance by the population, and no adverse
events were observed, except in one NB who showed a drop in oxygen saturation (88%),
with spontaneous return, and exclusion from the study was not necessary.The oropharyngeal administration of colostrum was only conducted during the first 3
days of life of the newborn, and even then, all the newborns were followed up until
hospital discharge.Regarding dosages, frequency of administration, duration of intervention, type of
milk, and benefit population (weight and gestational age), the studies are
divergent, making standardization and applicability in neonatal units difficult.Most studies reported the value of 0.2mL as the administered dosage, which was also
adopted for this study, with a frequency of every 3 hours for 3 consecutive days. In
the literature, the studies that adopted the same volume and frequency as our study
were the studies by Lee et al.One of the limitations of the present study is that the frequency, the dosage and the
period of performance of the protocol of oropharyngeal colostrum administration were
based on studies with preterm NB who had no malformations. It might be interesting
to conduct studies with larger colostrum volumes and higher frequency of colostrum
administration.The study population also differed from other studies regarding birth weight. As of
2018, the Ministry of Health, with the document on the Kangaroo Handbook,
recommended that the dosage administered should be determined by weight range, with
dose values ranging from 0.2mL to 0.6mL, and associating colostrum therapy with the
Kangaroo Method, a standardized protocol for better neonatal outcomes.This guideline may be used in future studies with a larger number of
participants.Our initial hypothesis was that NBs with simple gastroschisis could benefit from
oropharyngeal colostrum administration with regard to early initiation of oral
feeding.The applicability of this strategy is related to the importance of the oral mucosa
and oropharynx for immune development and, consequently, of the gastrointestinal
tract.Dysmotility is a type of intestinal dysfunction expected in gastroschisis. However,
the results of our study showed that the introduction of enteral feeding with human
milk occurred with a median of 15 days, corroborating the findings of other
studies.In our study, intestinal dysmotility, found in 8 NBs in the control group and in 13
in the intervention group, was not observed during the use of colostrum therapy. It
was related to episodes of vomiting, abdominal distension and difficulty in diet
progression, which made it necessary to suspend the diet or reintroduce it slowly
with human milk or hydrolyzed formula. Newborns who presented feeding reactions
after initiating enteral feeding were not excluded from the analysis.Oropharyngeal colostrum is not included in the nutritional protocol for simple
gastroschisis at this institution. The practice is to feed newborns breast milk in
the first days of life. Findings reinforce the prior knowledge of the importance of
early nutrition, especially with human milk during the entire hospitalization
period.This was one of the first studies to apply the protocol for oropharyngeal colostrum
administration to neonates with malformations, and our study had some considerable
limitations.The first difficulty encountered in conducting the present study was regarding the
input parameters for calculating the sample size because there are no publications
on the use of colostrum therapy in NBs with gastroschisis, so we used studies of
clinical trials with preterm NB without malformations as a basis. Studies that used
breast milk in NBs with gastroschisis did not use colostrum, except for those that
suggested a protocol of oral hygiene with colostrum or breast milk.This study was conducted at a reference center for comprehensive care, with preand
postnatal follow-up and clinical neonatal and surgical management for NBs. Thus, the
bias related to births in another health unit were reduced. However, this single
study center may also be a limitation of the study, even considering the increase in
the prevalence of gastroschisis in recent years.At the study institution, the pregnant women are welcomed and scheduled for several
prenatal consultations with specialists in medicine, nutrition, genetics, social
work, milk bank, psychology. In some of these consultations, the women were
approached to participate in this study. Concomitantly, the study was explained in
collegiate groups, in meetings with supervisors and managers (neonatal and neonatal
surgery) and in the sectors where the mother was after delivery (rooming-in and ward
for pregnant women) and during shift changes because the project was not a hospital
routine.Among the hospital units, there is surgical mapping for monitoring births; however,
even with the knowledge of this schedule, there was still a loss of NBs in the study
because strict controls were not followed.During the coronavirus disease 2019 (COVID-19) pandemic, more specifically the period
from April to August 2020, the neonatal unit underwent a rigorous cohort process to
control the flow of employees, and research in this sector was suspended. These
circumstances led to the interruption of the project during this period and the
noninclusion of 15 eligible NBs for the study.