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

Primary Purpose

Bottle Feeding, Premature

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Experimental SLP
Experimental SEP
Sponsored by
Polish Mother Memorial Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bottle Feeding focused on measuring Premature Infant, Bottle Feeding, Side-lying Position, Semi-elevated Position, Oral Feeding

Eligibility Criteria

32 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Polish Mother's Memorial Hospital- Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental SLP

Experimental SEP

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Physiological stability
Oxygen saturation (SpO2) changes measured by using a pulse oximeter data
Physiological stability
Heart rate (HR) changes measured by using a pulse oximeter data
Qualitative aspect of bottle-feeding
Total time of declines of SpO2 ≤85%
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.
Qualitative aspect of bottle-feeding
Occurrence of choking episodes
Qualitative aspect of bottle-feeding
Duration of the feeding session
Qualitative aspect of bottle-feeding
Duration of feeding
Qualitative aspect of bottle-feeding
Proportion of milk consumed (volume of milk eaten relative to the expected volume)

Secondary Outcome Measures

Full Information

First Posted
January 30, 2021
Last Updated
September 18, 2021
Sponsor
Polish Mother Memorial Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04773613
Brief Title
The Impact of Positioning on Bottle-feeding in Preterm Infants. A Comparative Study PMMHHRI-2018/V/9-SZB
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
April 20, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Polish Mother Memorial Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bottle Feeding, Premature
Keywords
Premature Infant, Bottle Feeding, Side-lying Position, Semi-elevated Position, Oral Feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental SLP
Arm Type
Experimental
Arm Description
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)
Arm Title
Experimental SEP
Arm Type
Other
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Experimental SLP
Intervention Description
SLP was given to the infant during bottle-feeding.
Intervention Type
Other
Intervention Name(s)
Experimental SEP
Intervention Description
SEP was given to the infant during bottle-feeding.
Primary Outcome Measure Information:
Title
Physiological stability
Description
Oxygen saturation (SpO2) changes measured by using a pulse oximeter data
Time Frame
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)
Title
Physiological stability
Description
Heart rate (HR) changes measured by using a pulse oximeter data
Time Frame
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)
Title
Qualitative aspect of bottle-feeding
Description
Total time of declines of SpO2 ≤85%
Time Frame
Measured during feeding
Title
Qualitative aspect of bottle-feeding
Description
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.
Time Frame
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)
Title
Qualitative aspect of bottle-feeding
Description
Occurrence of choking episodes
Time Frame
Noticed during feeding
Title
Qualitative aspect of bottle-feeding
Description
Duration of the feeding session
Time Frame
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.
Title
Qualitative aspect of bottle-feeding
Description
Duration of feeding
Time Frame
Measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding
Title
Qualitative aspect of bottle-feeding
Description
Proportion of milk consumed (volume of milk eaten relative to the expected volume)
Time Frame
Measured in 10th minute of feeding and on the finish of the feeding (2 points of measurement)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna D Raczyńska, MSc
Organizational Affiliation
Polish Mother's Memorial Hospital- Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polish Mother's Memorial Hospital- Research Institute
City
Łódź
ZIP/Postal Code
93-338
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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