Clinical trial NCT04773613: The Impact of Positioning on Bottle-feeding in Preterm Infants. A Comparative Study PMMHHRI-2018/V/9-SZB
Official title: The Impact of Positioning on Bottle-feeding in Preterm Infants ≤34 Gestational Age. A Comparative Study of the Semi-elevated and Side-lying Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bottle Feeding
Premature
Keywords: Premature Infant
Bottle Feeding
Side-lying Position
Semi-elevated Position
Oral Feeding
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 42
Sex: ALL
Minimum age (years): 32
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: One of the challenges of modern neonatology is to identify the right and effective method that can improve oral feeding. Optimal feeding position may contribute to improving the quality and safety of bottle-feeding in premature infants.

Detailed description: PURPOSE: The aim of the study was to compare the advantages of semi-elevated (SEP) with side-lying positioning (SLP) during bottle-feeding of preterm infants.

METHOD: The study included forty two neonates (n=42) born ≤34 weeks of gestational age. Four bottle-feeding sessions were tested in each of the newborns: two in the SEP and two in the SLP. The position for the first study was randomly assigned, then positioning changed after each feeding session. In one day, only two consecutive feeding sessions which were included to the study in order to minimize fatigability as a disrupting factor. The levels of saturation (SpO2) and heart rate (HR) were measured as the parameters indicative of the newborn's physiological stability. The factors determining the qualitative aspect 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 choking episodes. The proportion of milk consumed (volume of milk eaten relative to the expected volume) and the duration of the feeding and feeding session were also recorded.

Eligibility criteria: 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.

Primary outcomes:
measure: Physiological stability
timeFrame: Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)
measure: Physiological stability
timeFrame: Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)
measure: Qualitative aspect of bottle-feeding
timeFrame: Measured during feeding
measure: Qualitative aspect of bottle-feeding
timeFrame: Measured 2 minutes before feeding session, in 3rd and 10th minutes of feeding, at the moment of finish of the feeding and in 10th minute after feeding (5 points of measurement)
measure: Qualitative aspect of bottle-feeding
timeFrame: Noticed during feeding
measure: Qualitative aspect of bottle-feeding
timeFrame: Measured from taking the baby out of bed before feeding to putting the baby to bed immediately after the intervention. Putting baby on parent's chest to kangaroo (Kangaroo Mother Care) after feeding instead to bed was also allowed.
measure: Qualitative aspect of bottle-feeding
timeFrame: Measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding
measure: Qualitative aspect of bottle-feeding
timeFrame: Measured in 10th minute of feeding and on the finish of the feeding (2 points of measurement)
Secondary outcomes:
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Polish Mother's Memorial Hospital- Research Institute
Study officials:
affiliation: Polish Mother's Memorial Hospital- Research Institute
name: Anna D Raczyńska, MSc
role: PRINCIPAL_INVESTIGATOR
References: