The Impact of Positioning on Bottle-feeding in Preterm Infants ≤34 Gestational Age. A Comparative Study of the Semi-elevated and Side-lying Position
Phase: NA
Conditions: Bottle Feeding, Premature
Sponsor: Polish Mother Memorial Hospital Research Institute

Study Protocol and Statistical Analysis Plan 
 
 
THE IMPACT OF POSITIONING ON BOTTLE-
FEEDING IN PRETERM INFANTS ≤34 
GESTATIONAL AGE. A COMPARATIVE 
STUDY OF THE SEMI-ELEVATED AND SIDE-
LYING POSITION 
 
 
NCT04773613 
 
 
 
Document date: 30.06.2018 
 
 

Study Protocol 
 
INTRODUCTION  
Progress in perinatal care results in the increase of preterm infants survivability. 
Preterm infants need basic life functions support with nutrition being one of 
these functions. Prematurely born infants often require gastric tube feeding. 
Transition from enteral (gastric tube) to oral feeding poses a problem for 
premature infants with cardiovascular and respiratory stability. Therefore, the 
transition is conducted gradually, taking into account, i.a. the stability of life 
functions, the maturation of orofacial area reflexes and the efficiency of 
articulation 
apparatus, 
suction-breathing-swallowing 
coordination, 
development of autoregulatory mechanisms which are associated with the 
ability to maintain the activity level which enables feeding. The 32-34 weeks 
postmenstrual age is usually the moment when premature infants are most likely 
to begin oral feeding, usually bottle-feeding (the maternal milk, milk from a milk 
bank, or modified milk). Later on, most premature infants achieve sufficient level 
of ability to initiate breast or mixed feeding. Indication of proper and effective 
operations that are aimed at improving the quality and safety of oral feeding is 
a challenging issue. 
One of significant aspects which may contribute to improvement of quality and 
safety of oral feeding of premature infants is the optimal feeding position. 
Feeding positioning applied in prematurely born children includes semielevated 
(SEP) and side-lying (SLP) positions as well as their modifications. 
Lack of complete oral feeding often causes delayed discharge of newborn infants 
from hospital, which may increase the risk of nosocomial patients’ infections as 
well as increasing the cost of hospitalization. Reduction of the factors that 
adversely affect the introduction of full, effective and safe oral feeding is a very 
important element of neonatal care. Unfavourable factors such as: saturation 
decrease, bradycardia or choking episodes are the causes or symptoms of the 
newborn’s stress which may also add to the stress in parents participating in the 
feeding process. Stress has an obvious detrimental effect on the development of 
immature brain, causing neuronal atrophy and changes in the hippocampus 
functioning as well as affecting the immune and neuroendocrine systems. Stress 
negatively affects mother’s lactation due to stress inhibitive effect on the 
secretion of hormones responsible for milk production. Safe introduction of oral 
feeding is one of stress-reducing factors for parents. Increased sense of safety 

and comfort, in turn, encourages parents of prematurely born infants to try baby 
feeding on their own. 
 
PURPOSE 
The aim of the study is to compare the advantages of SEP and SLP positioning 
during bottle-feeding of preterm infants ≤34 weeks gestational age. 
 
METHOD 
The study will include forty two neonates (n=42) born ≤34 weeks of gestational 
age. Four bottle-feeding sessions will be testes in each of the newborn: two in 
the SEP and two in the SLP. The position for the first study will be randomly 
assigned, then positioning will be changed after each feeding session. In one day, 
only two consecutive feeding sessions which will be included to the study in 
order to minimize fatigability as a disrupting factor. The levels of saturation 
(SpO2) and heart rate (HR) will be measured as the parameters indicative of the 
newborn’s physiological stability. The factors determining the qualitative aspects 
of feeding included the total time of declines of SpO2  ≤85%, level of the 
newborn’s alertness according to the Neonatal Behavioral Assessment Scale 
(NBAS), and the occurrence of chocking episodes. The proportion of milk 
consumed (volume of milk eaten relative to the expected volume) and the 
duration of the feeding and feeding session will be also recorded.  
Each feeding session will be recorded with a video camera. It should be 
mentioned that participation in the study will not oblige the parents to use any 
of the positions which will be used during the study and to bottle-feeding. Bottle-
feeding will be continued with attempts of the breastfeeding, if only it will be 
possible. 
 
INCLUSION CRITERIA 
• circulatory and respiratory stability; 
• readiness for oral feeding according to each child's Speech-Language 
Pathologist assessment; 
• prematurely born infants who were in the process of being transferred 
from enteral nutrition (or enteral nutrition + parenteral nutrition) to full 

oral feeding and were fed orally at least 4- 6 times within twenty-four 
hours; 
• parents gave informed consent to participate their infant in the study. 
 
EXCLUSION CRITERIA 
• disorders which could significantly affect the feeding course, such as cleft 
lip and/or palate, facial paralysis and/or congenital defects of the facial 
skeleton; 
• the presence of detected congenital abnormalities and metabolic 
diseases; low Apgar score (less than 5 points at the 5th and 10th minute 
of the measurement); 
• administered analgesics, anticonvulsants and sedatives; 
• <72 hours from extubation prior the trial; 
• parents refusal to participate in the study or when bottle-feeding was 
not the parental preference. 
 
 
DETAILS OF POSITIONING IN SLP AND SEP POSITIONS  
 
SLP: Infant placed in a SLP on the researcher’s lap. Head of the infant 
symmetrically placed between the shoulders, supported by the researcher’s. 
Shoulder girdle higher than pelvic girdle, head and back in a straight line – a 
slight natural bent of the body is allowed. Legs bend at an angle of approx. 90˚ 
in the natural flexion of the knee and ankle joint. The infant’s arms close to the 
midline (on the bottle of researcher’s hands). 
SEP: Infant placed in a SLP on the researcher’s lap. The head rests on the 
researcher’s hand. Shoulder girdle higher than pelvic girdle, head and back in a 
straight line at an angle of 40-45˚to the ground – a slight natural bend of the 
body is allowed. Legs bend at an angle of approx. 90˚ in the natural flexion of 
the knee and ankle joint. The infant’s arms close to the midline (on the bottle 
of researcher’s hands). 
 

The research is approved by the Bioethical Commission of the Polish Mother’s 
Memorial Hospital Research Institute, Łódź, Poland - opinion no. 95/2016. 
 
STUDY DESIGN 
The study is designed as as a crossover study - alternate study. It will be a 
randomized trial. Each infant will be bottle-fed four times: twice in the SEP and 
twice in the SLP. In each of the study positions 84 feeding sessions will be 
analyzed (total amount of feeding sessions which will be analyzed will be 168). 
The position for the first trial will be randomly assigned (random table), then 
positioning will be changed after each feeding session. The study will include 
observation of the newborn before, during and after the feeding and the 
following measurements: 
 
A. 2 minutes before the feeding session: oxygen saturation (SpO2) level, 
heart rate (HR) (pulse oximeter data), alertness level 
B. 3rd minute of the feeding session: SpO2, HR, alertness level 
C. 10th minute of the feeding session: SpO2, HR, alertness level, volume of 
food eaten 
D. the end of the feeding session: SpO2, HR, alertness level, volume of food 
eaten 
E. 10 minutes after the feeding session: SpO2, HR, alertness level 
 
The declines of SpO2  ≤85% level, total time of feeding and feeding session, 
occurrence chocking episodes also will be recorded.  
 
During the study feeding, normal feeding session procedures will be applied: 
avoidance of excessive stimuli by ensuring calm environment with limited level 
of light and noise, pauses in the feeding after a series of suckling (interval 
feeding), manual support within the articulation apparatus to improve lip 
tightness and/or mandibular function. Stimulation of the suction reflex will be 
also allowed. 
 
 

Statistical Analysis Plan 
 
In order to verify hypothesis stated in this research, statistical analysis will 
be conducted using IBM SPSS v. 25 and Jamovi v1.2.8. Frequency distribution 
analysis, basic descriptive statistics with Shapiro-Wilk's test for normality of 
distributions,  t-tests for independent samples, two-way independent mixed 
ANOVAs as well as chi-squared tests of independency will be computed. 
 
WHAT WILL BE ANALYZED? 
 
• Differences in changes in blood oxygen saturation due to the position of 
the baby during feeding 
• Heart rate variations due to the position of the baby during feeding 
• Differences in the change in baby's activity due to the baby's position 
during feeding 
• The position of the baby during feeding and choking episodes 
• Differences in the proportion of the volume of eaten food due to the 
position of the child during feeding 
• Differences in feeding times and feeding sessions due to the position of 
the baby during feeding 
• Differences in the time of saturation decrease to the level of ≤ 85% due to 
the position of the child during feeding 
 
 
 
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