Back to resultsA Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.
Primary Purpose
Bottle Feeding, Premature
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Experimental SLP-R
Experimental SLP-L
Sponsored by
About this trial
This is an interventional prevention trial for Bottle Feeding focused on measuring Premature Infant, Bottle Feeding, Side-lying Position, Oral Feeding
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 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.
Sites / Locations
- Polish Mother's Memorial Hospital - Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental SLP-R
Experimental SLP-L
Arm Description
Infant placed in a SLP-R on the researcher's lap. Infant body positioned on side-lying position on the right side of it's body. 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 SLP-L on the researcher's lap. Infant body positioned on side-lying position on the left side of it's body. 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).
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% measured by using a pulse oximeter data
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
Occurence of posseting and regurgitations
Qualitative aspect of bottle-feeding
Duration of the feeding session
Qualitative aspect of bottle-feeding
Duration of feeding
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
NCT ID
NCT04987983
First Posted
July 14, 2021
Last Updated
March 19, 2023
Sponsor
Polish Mother Memorial Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04987983
Brief Title
A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.
Official 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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 28, 2021 (Actual)
Primary Completion Date
September 8, 2021 (Actual)
Study Completion Date
September 23, 2021 (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
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.
Detailed Description
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.
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, Oral Feeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental SLP-R
Arm Type
Experimental
Arm Description
Infant placed in a SLP-R on the researcher's lap. Infant body positioned on side-lying position on the right side of it's body. 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 SLP-L
Arm Type
Experimental
Arm Description
Infant placed in a SLP-L on the researcher's lap. Infant body positioned on side-lying position on the left side of it's body. 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).
Intervention Type
Other
Intervention Name(s)
Experimental SLP-R
Intervention Description
SLP-R will be given to the infant during bottle-feeding.
Intervention Type
Other
Intervention Name(s)
Experimental SLP-L
Intervention Description
SLP-L will be 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% measured by using a pulse oximeter data
Time Frame
Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)
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
Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)
Title
Qualitative aspect of bottle-feeding
Description
Occurence of posseting and regurgitations
Time Frame
Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)
Title
Qualitative aspect of bottle-feeding
Description
Duration of the feeding session
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.
Title
Qualitative aspect of bottle-feeding
Description
Duration of 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
Title
Qualitative aspect of bottle-feeding
Description
Duration of 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
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 - maximum in 40th minute of feeding (maximum time of feeding is 40 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
38 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna D Raczyńska, PhD
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
A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.
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