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

Premature Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773613
• Other study ID #: PMMHRI
• Status: Completed
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: April 20, 2020

Study information

• Verified date: February 2021
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Weeks and older

Eligibility

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.

Related Conditions & MeSH terms

• Bottle Feeding
• Premature
• Premature Birth

Intervention

Other:
• Experimental SLP
SLP was given to the infant during bottle-feeding.
• Experimental SEP
SEP was given to the infant during bottle-feeding.

Locations

Country	Name	City	State
Poland	Polish Mother's Memorial Hospital- Research Institute	Lódz

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Qualitative aspect of bottle-feeding	Total time of declines of SpO2 =85%	Measured during feeding
Primary	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)
Primary	Qualitative aspect of bottle-feeding	Occurrence of choking episodes	Noticed during feeding
Primary	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.
Primary	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
Primary	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)