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

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

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.

Study Overview

• Status: Completed
• Conditions: Bottle Feeding; Premature
• Intervention / Treatment: Other: Experimental SLP; Other: Experimental SEP

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Łódź, Poland, 93-338
    • Polish Mother's Memorial Hospital- Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: Experimental SLP; SLP was given to the infant during bottle-feeding.
Other: 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)	Other: Experimental SEP; SEP was given to the infant during bottle-feeding.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Polish Mother Memorial Hospital Research Institute
• Investigators: Principal Investigator: Anna D Raczyńska, MSc, Polish Mother's Memorial Hospital- Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: January 30, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Bottle Feeding; Premature Infant; Side-lying Position; Semi-elevated Position; Oral Feeding
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: PMMHRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No