The Impact of Positioning on Bottle-feeding in Preterm Infants. A Comparative Study PMMHHRI-2018/V/9-SZB

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Positioning on Bottle-feeding in Preterm Infants ≤34 Gestational Age. A Comparative Study of the Semi-elevated and Side-lying Position

Conditions
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Bottle Feeding, Premature

Intervention / Treatment
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* Other: Experimental SLP
* Other: Experimental SEP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental SLP<br>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 the pelvic girdle, head and back in a straight line - a slight natural bend of the body is allowed. Legs bent 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 or researcher's hands) | Other: Experimental SLP<br>* SLP was given to the infant during bottle-feeding.<br>|
| Other: Experimental SEP<br>Infant placed in a SEP on the researcher's lap. The head rests on the researcher's hand. Shoulder girdle higher than the pelvic girdle, head and back in a straight line at an angle of 30-45° to the ground - slight, natural body bend is allowed. Legs bent 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 or researcher's hands) | Other: Experimental SEP<br>* SEP was given to the infant during bottle-feeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological stability | Oxygen saturation (SpO2) changes measured by using a pulse oximeter data | 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) | 
| Physiological stability | Heart rate (HR) changes measured by using a pulse oximeter data | 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) | 
| Qualitative aspect of bottle-feeding | Total time of declines of SpO2 ≤85% | Measured during feeding | 
| Qualitative aspect of bottle-feeding | Level of the newborn's alertness changes according to the 6-point Neonatal Behavioral Assessment Scale, where individual points mean: 1 - quiet sleep, 2 - active sleep, 3 - drowsy, 4 - quiet alert, 5 - active alert, 6 - crying. This is descriptive, qualitative scale which shows changes of newborn's activity. | 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) | 
| Qualitative aspect of bottle-feeding | Occurrence of choking episodes | Noticed during feeding | 
| Qualitative aspect of bottle-feeding | Duration of the feeding session | 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. | 
| Qualitative aspect of bottle-feeding | Duration of feeding | Measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding | 
| Qualitative aspect of bottle-feeding | Proportion of milk consumed (volume of milk eaten relative to the expected volume) | Measured in 10th minute of feeding and on the finish of the feeding (2 points of measurement) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Infant, Bottle Feeding, Side-lying Position, Semi-elevated Position, Oral Feeding