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

Not Applicable

Completed

• Conditions: Premature; Bottle Feeding
• Interventions: Other: Experimental SLP; Other: Experimental SEP

• Registration Number: NCT04773613
• Lead Sponsor: Polish Mother Memorial Hospital Research Institute

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.

Study Timeline

• Study Start: 2018-07-19
• Primary Completion: 2020-04-20
• Study Completion: 2020-04-20
• Study First Submitted: 2021-01-30
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-26
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental SLP	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)
Experimental SEP	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)

Primary Outcome Measures

Name	Time	Method
Qualitative aspect of bottle-feeding	Measured in 10th minute of feeding and on the finish of the feeding (2 points of measurement)	Proportion of milk consumed (volume of milk eaten relative to the expected volume)
Physiological stability	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)	Heart rate (HR) changes measured by using a pulse oximeter data

Trial Locations

Locations (1)

Polish Mother's Memorial Hospital- Research Institute; 🇵🇱 Łódź, Poland