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Completed

NCT Number: NCT04987983

A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.

Methods and techniques to improve the quality and safety of oral feeding in preterm infants are still a significant challenge in modern neonatology. One of the areas that can help improve feeding is choosing the optimal feeding position for premature babies.

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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–38 week

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 is to compare the advantages of side-lying positioning on the right (SLP-R) and left side (SLP-L) of infant's body, during bottle-feeding of preterm infants.

METHOD: The study will include eight neonates (n=8) born ≤34 weeks of gestational age. Four bottle-feeding sessions will be tested in each of the newborns: two in the SLP-R and two in the SLP-L. The position for the first study will be randomly assign, then positioning will be change after each feeding session. In one day, only two consecutive feeding sessions will be tested which will be included to the study in order to minimize fatigability as a disrupting factor. The levels of saturation (SpO2) and heart rate (HR) will be measured as the parameters indicative of the newborn's physiological stability. The factors determining the qualitative aspect of feeding include 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 will be record. Maximum time of feeding session will be 40 minutes.

Also the posseting during/after feeding and regurgitations will be record in each tested positions.

Who can participate

Healthy volunteers accepted: Yes

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 will be in the process of transfer from enteral nutrition to full oral feeding and will be fed orally at least 4 times within twenty-four hours;
  • researcher must be a right handed person (right hand is the dominant hand);
  • each infant will be fed with one kind of bottle and nipple;
  • parents will give a 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;
  • newborns after abdomen chirurgical treatment;
  • 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;
  • parenterally fed infants;
  • infants with administered intravenous infusion with glucose;
  • parents refusal to participate in the study or when bottle-feeding will not be the parental preference.

Treatment and study plan

Experimental SLP-R

Other

SLP-R will be given to the infant during bottle-feeding.

Experimental SLP-L

Other

SLP-L will be 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: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)

    Total time of declines of SpO2 ≤85% measured by using a pulse oximeter data

  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: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)

    Occurrence of choking episodes

  6. Qualitative aspect of bottle-feeding

    Time frame: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)

    Occurence of posseting and regurgitations

  7. Qualitative aspect of bottle-feeding

    Time frame: Up to 1 hour - 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

  8. Qualitative aspect of bottle-feeding

    Time frame: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes) - measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding

    Duration of feeding

  9. Qualitative aspect of bottle-feeding

    Time frame: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes) - duration of feeding is measured from insertion of the nipple to the infant's mouth to the moment when baby finish the feeding

    Duration of feeding

  10. Qualitative aspect of bottle-feeding

    Time frame: Measured in 10th minute of feeding and on the finish of the feeding - maximum in 40th minute of feeding (maximum time of feeding is 40 minutes)

    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

A Comparison Study of the Bottle-feeding of Prematurely Born Infants (≤ 34 Weeks of Gestational Age) in Side-lying Position, Positioned on the Right and Left Side - a Pilot Study.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Mar 21, 2023

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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