SECTION I

Oral immunotheraphy through administration of oropharyngeal colostrum may improve of health conditions for
premature newborn infants weighing less than 1.5 Kg. This early day’s treatment approach aims to thwart intestinal
lesions as well as infections, malnutrition and death in such a vulnerable group – a major challenge faced by the neonatal
care team.
Prematurity spurs complications which end up in more than a million worldwide death of newborn children every year.
Whether they get to survive delivery, newborn children on average present height or weight deficits. Every so often they weigh
less than 1.5 Kg due to development disruption during the crucial phase of faster organ maturation and growth. This results in
organic, metabolic and immunological vulnerability. During the last pregnancy trimester, fetus are exposed to immune
protection factors such as cytokines, antibodies and lactoferrin through the swallowing and aspiration of amniotic fluid, a
process which spurs organs’ maturation and growth. Nevertheless, children born before this period are deprived of such
exposition benefits. Thus, these newborn children demand special care procedures which include parental nutritional therapy (as
during such growth stage enteral nutrition in an immature intestine may trigger harsh wounds). In spite of the advances in such
area, so far traditional therapies have not been able to prevent rapid intestinal atrophy and the pathogenic colonization of the
preterm intestine due to the gastrointestinal tract lack of use period. This has the increased risk of infections, intestinal wounds;
full enteral feeds are reached later, poor nutritional performance or even death as a likely outcome.
As an attempt to prevent such conditions, a strategy has been proposed for to mimic the fetal environment. Considering
that some of the previously mentioned biological factors are also present in human milk - say it mainly in the colostrum and in
much higher concentrations than in the amniotic fluid (and in even superior concentrations in premature children’s breastfeeding
mothers’ milk) - it is suggested that immunotheraphy through the oropharyngeal administration of colostrum drops may be
adopted as a natural alternative to preserve the benefits provided by the in womb environment and make the post natal life
transition easier. The colostrum oropharyngeal administration of immunological factors, beyond being a low cost, well tolerated
and easy to apply technique, can also stimulate the oropharynx lymphatic tissue, resulting in the activation of T cells and their
systemic broadcast, bringing benefits to several organs. In addition, exposure to breast milk after birth can reduce the pathogenic
colonization of the intestine, and can foment a protective flora as well as the inflammatory response modulation and may thus
reduce the risk of intestinal injuries and infections.
Other benefit generated by the use of colostrum is the early stimulus of lactogenesis, which contributes to a greater
success in breastfeeding and the strengthening of the mother-child connection. This is very significant, since factors such as the
long period of internment, the difficult contact with the monitored newborn child and the longer time to start breastfeeding are
intrinsic to increasing mother’s stress and anxiety. All of the formerly mentioned combined usually results in breastfeeding
failure in the conventional therapies.
With the introduction of the colostrum based immunotherapy, it is expected that neonatal mortality gets reduced as
well as that the time for the newborn to reach a full diet. The improvement of the infant’s nutritional status, briefer hospital
stays, and the diminishment of the occurrence of necrotizing enterocolitis and sepsis in premature children with less than 1,5kg
are also expected outcomes. Furthermore, the broadcasting of this technology in the neonatal units linked to the Brazilian public
network through educational media is intended.
Preventive measures like this are far more effective than conventional treatments, after the onset of an illness, and
have a greater impact on neonatal mortality. Oropharyngeal administration of colostrum is an affordable and potentially
beneficial intervention with biological plausibility for diseases’ prevention in the highly vulnerable population of newborn
infants under 1.5 Kg. Nevertheless, only randomized clinical trials can definitively guarantee the safety and efficiency of this
technique in the avoidance of diseases and improvement of the general health of this population.
This study will be carried out in Feira de Santana, a medium-sized city in the poorest region of Brazil, the Northeast.
This municipality is located in the northern region of the state of Bahia, between the reconcave and semi-arid Northeastern,
which comprises the so called droughts’ polygon. According to the latest census, Feira de Santana has a total population of
556,642 inhabitants. 38.7% of it with monthly income per capita of less than U$ 145, HDI (Human Development Index) of
0.712, infant mortality toll of 17.59 deaths per every thousand live births and only 59.7% of its population has access to
adequate sewage systems. In 2016, the Municipal Health Department of Feira de Santana had registered the birth of 177
newborns under 1.5 Kg and the early neonatal deaths (0 to 6 days) of 54 newborns with the same features. Thus, about 350
premature children could be positively impacted with this intervention.
The municipality got qualified for the full management of the municipal health system in 2004 and has 148 health
facilities, two maternity hospitals with neonatal ICUs that have two human milk banks attached to maternal and child care units
on their turn linked to the public network – Universal Health System (or SUS). It is imperative to note that these were the first
two human milk banks in the state, highlighting Feira de Santana as a reference in the issue within the region. Breastfeeding
keeps on being a relevant theme in the city, with intense teaching and research development in the area, especially through the
Research and Extension Center of the Feira de Santana State University (UEFS), the same institution where this initiative
started. UEFS has already published dozens of articles in this domain. Now, the city will once again emerge as a reference for
the dissemination of colostrum oral immunotherapy throughout the country, mainly due to the specialized educational media.
The study’s chosen site for the colostrum oral immunotherapy will be the Neonatal Units for Newborns of the Inácia
Pinto dos Santos Hospital (better known as “Woman's Hospital”), which is a medium-sized institution and also “the Baby
Friendly Hospital” since 1992. The Woman’s Hospital offers diverse outpatient services, such as hospital care for the women
and their newborn during high-risk pregnancy, delivery labor and puerperium. The Hospital is managed by the Feira de Santana
Hospital Foundation, a non-profit institution, with the indirect administration of the Municipal Network; and it meets
gratuitously the city's demand and all of its agreed surrounding micro-regions. Currently, there are 8 beds in the ICU and 6 beds
in the Intensive Care Unit (ICU).
This is an original, interventional, randomized, placebo-controlled, and double-blinded clinical trial.

SECTION II

The Immunotherapy with colostrum has a huge expansion prospective, considering its straightforwardness, low cost
of execution, healthy results and also, in the short term, the effortlessly verifiable financial outputs. The briefer hospitalization
time and the lower incidence of surgical interventions (thanks to the frequent intestinal lesions resultant from immunotherapy)
are the main key of this immediate saving. The spreading of results in scientific conferences and through the educational media
has the capacity of boosting this expansion to neonatal units across the country. Considering that Brazil is the world’s 10th
country in absolute number of premature births, with 279,3002 live births, there is a large public to be reached.
In the medium term, the regularity increase of successful breastfeeding due to the early stimulation performed for
immunotherapy will decrease costs with infant formulas, as well as lower health expenses, considering the lower incidence of
illnesses among breastfed children. Furthermore, the benefits of this intervention may be extended to other life phases, given
that the nutritional status improvement in the first 2 years is capable of preventing the occurrence of chronic diseases in
adulthood. Breastfeeding may also improve cognitive functioning, resulting in healthier individuals capable of promoting the
development of society.
The therapy accomplishment anticipation can be attributed to previous reports from studies results published in the
scientific community, which comprise clinical trials and case-controlled studies. In the initial period of 2 years, rooted in already
carried out studies, a neonatal mortality reduction in hospital institutions of 12.5% is expected, a 15% of reduction in the
occurrence of necrotizing enterocolitis, the 2 days earlier beginning of enteral feeding and heavier weight from the 36th week of
corrected age among the NB who received the intervention. Subsequent to the first 5 years of the Project initiation, it is expected
that the colostrum immunotherapy gets to be implemented in all public health network hospitals in Bahia. Throughout this
period, the Project will also track the cohort formed in its implantation, through active search at home; it is hoped to bring
positive results such as less occurrence of overweight / obesity, lower frequency of allergies and better cognitive performance in
children of 5 years of age; to date, no study had raised such an expressive data amount, which could provide us with estimates.
The project counts on the support of the State University of Feira de Santana (UEFS) for its execution, providing as a
counterpart: guiding teacher, support room for the study design, research group for the application of questionnaires, among
others. The project had primarily its own funding; however, we seek financial support from development institutions such as the
Foundation for Research Support of the State of Bahia, from which a resolution is still expected, and others which decide to
offer us their partnership. The institution in which the research will be carried out must take on the protocol for the execution of
the colostrum immunotherapy, once the positive final outputs of this intervention are on hand. As an instance, we intend to join
forces for the implementation of a protocol in the other institutions that adopt this technology from our broadcasting.
Immunotherapy with colostrum leads the prevention pratices typical characteristics of the primary care to high
complexity units such as the neonatal ICU, tightening the relationship between these two distinct sectors. Beyond that, it places
the breastfeeding woman at the center of the care focus, once she is the one who provides the precious liquid that is able to bring
on all the benefits scrutinized in this project, all in compliance with SUS principles - an integrated system between the State and
Society, which looks for the interaction towards a common aim: the promotion of health to the population, using the
fundamentals of integrality, universality, equity, decentralization and social control.
The funding obtained from the financing we are applying for are going to be used to the purchase of materials,
equipment and services directly interrelated to the stages of the immunotherapy, which include the intervention itself, the
collection and analysis of data and the broadcasting of results to other health institutions (see details in Table 01). Previous costs
of the planning phase are not included. The schedule for the execution of the steps can be seen in Table 02. The Colostrum
Immunotherapy execution methodology follows as seen below:
Premature newborns are included in this study (born ≤ 36 gestational weeks), whose birth weight is less than 1,500 g
and their mothers, once admitted to the ICU, without oral diet, clinically stable, with up to 48 hours do not present severe
anomalies. Among the exclusion criteria are: mothers with a drug use background, who display psychological disorders, who
underwent triplets multiple gestation or who are not recommended to breastfeeding (due to retroviruses and cytomegalovirus,
for instance); premature newborns under the usage of a vase constricting drug> 10mcg / kg / min, requiring immediate surgical
intervention, or with congenital syndromes and / or malformations. All likely subjects will be approached in the first 24 hours
postpartum in order to collect information regarding the implementation of the Protocol and will be invited to partake in the
research by signing the Free and Informed Consent Form. First a form will be used in order to obtain the social-demographic
and biological data available; then all the mothers will be referred to the human milk bank and encouraged to carry out manual
milking or to use the milk extraction pump, and they will be suitably educated towards hygienic sanitary procedures to
guarantee the supply process security to the newborn. Breastfeeding will be performed every 2 or 3 hours, totalizing up to 8
extractions every 24 hours, in order to stimulate lactogenesis. The colostrum will be stored in a sterile glass and immediately
sent to the distribution area, where it will be handled in a sterile flame field and distributed in 0.1 ml aliquots in tuberculin
syringes and kept under refrigeration at around 4 ° C. By the time of use, two syringes will be defrosted until they reach the
room temperature. The intervention group will receive the non pasteurized mother’s colostrum; when the mother’s milk is
absent, pasteurized colostrum stored in the milk bank will be used. When it comes to the control group, sterile distilled water
will be used as a placebo. The treatment schedule will be set up daily by eight administrations of 0.2 ml (or four drops) of
colostrum or distilled water, with 0.1 ml in each cheek for 5 seconds in the oropharyngeal tract every 3 hours until the seventh
day of life. Vital signs will be monitored during administration, and the procedure. The Intervention and Control groups will be
followed up until hospital discharge. This study will have a permanent sample group comprised of 180 subjects, totalizing 90 for
each group, α = 5%; ß = 80%, in accordance with the sample calculation in the statistical software. The random allocation
process between the Intervention and Control groups will be through Simple Randomization. Syringes containing breast milk or
distilled water will be labeled with a white adhesive that is large enough to wrap around its whole surface, avoiding the
identification of its contents and ensuring the blindness of the research. The data collected will be registered twice by different
typists in distinct banks, and then compared for validation in the software. Descriptive analyzes will be performed through the
use of frequency measures, such as the incidence of results and association measures, such as attributable risk, percentage and
relative risk, with a substantial disparity between the groups compared when p-value ≤ 0.05. In order to compare the occurrence
rates of the binary outcome between the groups, life tables and survival analysis techniques will be used.
This project was approved by the Ethics Research Committee with Human Beings of the local University and
submitted for the National Committee of Ethics in Research’s appreciation.

TABLE 01: BUDGET

CATEGORIES COST DESCRIPTION

notebook (1 unit/US$ 774.00), printer (1 unit/US$ 247.70), tablet (1 unit/US$

464.40), fetal sonar (5 units/US$ 1,393.20), neonatal stethoscope (4 units/US$
EQUIPMENTS US$ 7325.15 464.40), oximeter sensor (10 units/US$ 928.80), newborn positioner (30 units/US$
928.80), kenmore vertical freezer (2 units/US$ 1,548.00), pediatric balance (2
units/US$ 575.85)

sheet of A4 paper (10.000 units/US$ 123.90), sheet of A4 adhesive label (800

units/US$ 198.20), printer ink kit (2 units/ US$ 123.90), latex glove (22.400
units/US$ 1,387.00), disposable cap (11.200 units/US$ 1,040.25), disposable mask
SUPPLIES US$ 20410.15 with elastic (11.200 units/US$ 520.15), disposable long-sleeve shirt (11.200
units/US$ 5,201.25), disposable syringe 1 ml (12.000 units/US$ 743.05), sterile
distilled water (24.000 mL/US$ 111.45), statistical package (1 unit/US$ 10,836.00),
office package (1 unit/US$ 125,00)

producer of video (video of 10' on immunotherapy oral of colostrum/US$

SUBCONTRACTS US$ 18576.00 9,288.00), book Publisher (US$
9,288.00)

TRAVEL US$ 9288.00 Passage / Accommodation / Food / Transportation (US$ 9,288.00)

Nursing / Laboratory Technician (US$ 1548.00), typist (US$ 1238.40), statistician

PERSONNEL US$ 5263.20
(US$ 2476.80), translator (US$ 5000.00)

TOTAL US$ 65862.50

TABLE 02: SCHEDULE

2018 2019 2020

Activities o n d j f m a m j j a s o n d j f m a m j j a s o
u o e a e a p a u u g e c o e a e a p a u u g e c
c v c n b r r y n l o p t v c n b r r y n l o p t

Counter Signed x

Data collection x x x x x x x x x x x x x x x x x x x x x x x x

Create of the
x x x
Media

Dissemination of
x x x x x x x x x x x x x
the technique

Data Analysis x x x x x x x x x x x x x x x x x x x x x x x

Financial and
x x x x
Scientific Reports
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