Oral Colostrum Administration in Very Low Birth Weight Premature Infants Clinical Trial
Official title:
Analysis of the Effects of Oral Colostrum Administration in Very Low Birth Weight Premature Infants Who Cannot be Fed Orally on the Breastfeeding
In the literature, it is emphasized that oral colostrum administration in very low birth
weight infants supported the immune development of the premature newborn, contributed to the
development of oral microbiota and reduced the length of hospital stay (Manzoni 2011; Pammi
2011; Zhang 2017; Moreno‐Fernandez 2018; Rodriguez 2009). However, there was no source
answering the question of how both the mother and the infant are affected by oral colostrum
administration in very low birth weight infants. Based on the studies indicating that
premature infants distinguished their mother's milk smell and taste (Lecanuet and Schoal,
1996; Aoyama et al. 2010), it was aimed to find answers to the questions of whether this
administration in infants without oral intake had positive effect on the success of
breastfeeding.
Research Hypotheses:
H0: Oral colostrum administration in very low birth weight premature infants who cannot be
fed orally has no effect on breastfeeding.
H1: Oral colostrum administration in very low birth weight premature infants who cannot be
fed orally affects the success of breastfeeding
Background: Premature newborns are physiologically and structurally different from mature
newborns, and these differences also bring along many health problems. Healthy growth and
neurodevelopmental needs of premature infants are evolutionarily met by providing breast
milk, which is a unique and natural food with excellent content. The importance of breast
milk in the nutritional management of premature and risky newborns has been well documented
by the American Academy of Pediatrics (American Academy of Pediatrics. 2012), and colostrum
with rich content especially in breast milk is the perfect first immunostimulant in infants.
In the literature, it is emphasized that oral minimal colostrum administration in very low
birth weight infants supports the development of immunity, contributes to the development of
oral microbiota and reduces the length of hospital stay (Manzoni 2011; Pammi 2011; Zhang
2017; Moreno‐Fernandez 2018; Rodriguez et al. 2009; Rodriguez et al. 2010).
In the intrauterine period, while the development of the sense of smell is completed at
gestational weeks 26-28, the development of the sense of taste is completed at week 18. The
fact that premature newborn is physically and neurologically insufficient after birth, and
the failure of environmental factors to meet the sensory needs (smell, taste, touch, sight,
hearing) in the intensive care environment outside the safe intrauterine environment during
the critical period negatively affect the newborn. The sense of smell is related to the sense
of taste and is a rapidly developing "chemical" sense. In the literature, it is reported that
familiar and pleasant tastes and smells facilitate the psychophysiological adaptation of
premature newborns to the first environment and contribute to mother-infant attachment
(Lipchock et al. 2011; Henderson 2011). The fats secreted from montgomery bodies (small
mounds on the areola) in the newborn's mother's breast have the same chemical structure and
smell of the amniotic fluid. This special similarity supports the sensory development of the
newborn and also helps the newborn to find and grasp the mother's breast (Henderson 2011;
Mennella and Ventura 2011). In the studies, it is reported that the taste and smell of breast
milk have effects on increased sucking movements of the newborn, early transition to oral
feeding and soothing (Aoyama et al. 2010; Bingham, Abassi and Sivieri 2003). It is considered
that there are many factors that affect the breastfeeding experience, and that one of the
most important of these experiences is the newborn's gaining sensory experience for the
senses of smell and taste until the first breastfeeding experience. Based on the studies
indicating that premature infants distinguish their mother's milk smell and taste (Lecanuet
and Schoal, 1996; Aoyama et al. 2010), it is considered that the newborns will positively
affect the breastfeeding with the oral colostrum administration. The aim of this study was to
analyze the effect of oral (oropharyngeal) colostrum administration in very low birth weight
premature infants (between 1000-1500 gr) who cannot be fed orally on the success of
breastfeeding.
Method: This is a randomized controlled experimental study. All very low birth weight infants
born to primiparous mothers hospitalized in the Neonatal Intensive Care Unit of Sakarya
University Training and Research Hospital, Ministry of Health between February and November
2020 will constitute the population of the study. The sample of the study was calculated in
accordance with the intervention group selection criteria and by performing power analysis.
Power analysis was performed using G*Power (v3.1.7) program in order to determine sample
size. The effect range value was taken as 0.70 as the method used in cases where it is
unknown how many units difference is significant between the groups. In cases where Type 1
error probability (α) was 0.05 (at a confidence level of 95%), at a power level of 80% and
the effect range was 0.70, the study was planned with a total of 68 mothers, including 34
mothers women for each group. In the study, randomization will be determined by the urn
method. The urn method is used as a method equivalent to full randomization. In this method,
two parameters such as α and β are mentioned. These parameters refer to balls in two
different colors, red and white. α can be white or red, and β will be the exact opposite of
them. One of the balls is randomly selected and if the selected ball is white, the individual
is allocated into group α, and if it is red, then the individual is allocated into group β.
This process is repeated in each allocation (Kanık et al. 2011). In the study, the red
colored ball constituted the study group and the white colored ball constituted the control
group. In the case of an infant who meets the sampling criteria, these balls prepared by the
researcher will be placed in a black pouch and a nurse currently working in the unit will be
asked to make a choice with her eyes closed. The infant will be allocated into the study or
control group according to the color of the selected ball. Thus, the infants will be randomly
allocated into both groups.. The sample of the study will be randomly allocated into two
groups: the intervention group will be administered with oral colostrum, and the other group,
which was the control group, will be followed up by oral care with sterile physiological
saline in routine care of the service. Single-blind (researchers are not blind) randomization
will be provided since the mothers will be provided with education on the importance of oral
colostrum administration and milking techniques by the researchers. The statistician was also
blinded for the data analysis purpose. Data collection will be conducted in five stages. In
the first stage of data collection, the information in the "Mother-Preterm Introductory
Information Form" including socio-demographic characteristics in the study and control groups
before colostrum administration, and the information in "Preterm Follow-up Form" including
questions related to physiological parameters, body measurements and nutrition will be
obtained. In the second stage, oral colostrum, which was initiated when the neonatologist
determined that the newborn in the study group was stable, will be administered once every 3
hours and for at least 5 days until the newborn begins oral feeding. In accordance with the
oral colostrum protocol, a total of 0.2ml colostrum will be administered in approximately 1
minute for infants weighing between 1001-1500 g. The infants in the control group will be
followed up in routine service care. In the third stage, the information in the "Preterm
Follow-up Form" will be obtained after oral colostrum administration in the study group. The
same data will be obtained from the control group simultaneously with the study group. In the
fourth stage, the effectiveness of the first breastfeeding will be evaluated by the observers
in both groups using the Bristol Breastfeeding Assessment Tool. In the last stage, one week
after the first breastfeeding sucking / breastfeeding experience will be evaluated again. In
the evaluation of data, statistical analyses will be performed using the SPSS package
program. The Kolmogorov-Smirnov (K-S) test will be used for normality. In order to determine
whether there is a difference in the dependent variables compared to independent variables,
the independent group t-test will be used if the distribution is normal in independent
variables with two options, and Mann Whitney-U test will be used if distribution is not
normal. The results will be evaluated at a confidence level of 95% and at a level of
significance of p<0.05.
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