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NCT Number: NCT04773613

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

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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Key information

Conditions

Bottle Feeding Behavior Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Premature Birth Urogenital Diseases

Age range

32 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polish Mother's Memorial Hospital- Research Institute

Lodz, 93-338, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental SLP

Other

SLP was given to the infant during bottle-feeding.

Experimental SEP

Other

SEP was given to the infant during bottle-feeding.

Primary outcomes

  1. Physiological stability

    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)

    Oxygen saturation (SpO2) changes measured by using a pulse oximeter data

  2. Physiological stability

    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)

    Heart rate (HR) changes measured by using a pulse oximeter data

  3. Qualitative aspect of bottle-feeding

    Time frame: Measured during feeding

    Total time of declines of SpO2 ≤85%

  4. Qualitative aspect of bottle-feeding

    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)

    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.

  5. Qualitative aspect of bottle-feeding

    Time frame: Noticed during feeding

    Occurrence of choking episodes

  6. Qualitative aspect of bottle-feeding

    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.

    Duration of the feeding session

  7. Qualitative aspect of bottle-feeding

    Time frame: Measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding

    Duration of feeding

  8. Qualitative aspect of bottle-feeding

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Polish Mother Memorial Hospital Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2021
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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