The Impact of Positioning on Bottle-feeding in Preterm Infants. A Comparative Study PMMHHRI-2018/V/9-SZB
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2020
CompletedFirst Submitted
Initial submission to the registry
January 30, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedSeptember 24, 2021
February 1, 2021
1.8 years
January 30, 2021
September 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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)
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)
Qualitative aspect of bottle-feeding
Total time of declines of SpO2 ≤85%
Measured during feeding
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)
Qualitative aspect of bottle-feeding
Occurrence of choking episodes
Noticed during feeding
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.
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
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)
Study Arms (2)
Experimental SLP
EXPERIMENTALInfant 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)
Experimental SEP
OTHERInfant 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Polish Mother's Memorial Hospital- Research Institute
Lodz, 93-338, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna D Raczyńska, MSc
Polish Mother's Memorial Hospital- Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 30, 2021
First Posted
February 26, 2021
Study Start
July 19, 2018
Primary Completion
April 20, 2020
Study Completion
April 20, 2020
Last Updated
September 24, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share