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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2020-04-20

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.

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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.

Conditions

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Bottle Feeding Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental 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 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)

Group Type EXPERIMENTAL

Experimental SLP

Intervention Type OTHER

SLP was given to the infant during bottle-feeding.

Experimental SEP

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)

Group Type OTHER

Experimental SEP

Intervention Type OTHER

SEP was given to the infant during bottle-feeding.

Interventions

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Experimental SLP

SLP was given to the infant during bottle-feeding.

Intervention Type OTHER

Experimental SEP

SEP was given to the infant during bottle-feeding.

Intervention Type OTHER

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.

Minimum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No