Bottle FeedingNCT04987983
A Comparison Study of Feeding Prematures in the Side-lying Position on the Right and Left Side - a Pilot Study.
A study testing Experimental SLP-R and Experimental SLP-L in people with Bottle Feeding and Premature, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 38 weeksHealthy volunteers can take part
- Conditions the study is for
- Bottle Feeding, Premature
- What is being tested?
- Experimental SLP-R and Experimental SLP-L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 sitePoland
- Study dates
- 28 Jun 2021to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 38 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Polish Mother's Memorial Hospital - Research Institute
Lodz, 93-338
About this 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.
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.
Read the 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.
- Conditions
- Bottle Feeding, Premature
- Being tested
- Experimental SLP-R, Experimental SLP-L
- Keywords
- Premature Infant, Bottle Feeding, Side-lying Position, Oral Feeding
- Medical subject headings
- Bottle Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental SLP-ROther
SLP-R will be given to the infant during bottle-feeding.
Experimental SLP-LOther
SLP-L will be given to the infant during bottle-feeding.
| Study group | Role | What they receive |
|---|---|---|
| Experimental SLP-R | Experimental | 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) Receives: Other: Experimental SLP-R |
| Experimental SLP-L | Experimental | 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). Receives: Other: Experimental SLP-L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological stability
Oxygen saturation (SpO2) changes measured by using a pulse oximeter data
Measured: 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: 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 by using a pulse oximeter data
Measured: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)
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: 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
Measured: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)
Qualitative aspect of bottle-feeding
Occurence of posseting and regurgitations
Measured: Up to 40 minutes - measured during feeding session (maximum time of feeding session is 40 minutes)
Qualitative aspect of bottle-feeding
Duration of the feeding session
Measured: 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.
Qualitative aspect of bottle-feeding
Duration of feeding
Measured: 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
Qualitative aspect of bottle-feeding
Duration of feeding
Measured: 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
Qualitative aspect of bottle-feeding
Proportion of milk consumed (volume of milk eaten relative to the expected volume)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start28 Jun 2021
- Primary completion8 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bottle FeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Mother Memorial Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Raczyńska, Polish Mother Memorial Hospital Research Institute
- Investigators
- Anna D Raczyńska, PhD, Principal investigator, Polish Mother's Memorial Hospital - Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987983
- Sponsor's protocol ID
- PMMHRI-2021
- Status last verified
- Mar 2023
- First submitted
- 14 Jul 2021
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04987983
- Acronym / sponsor ID
- PMMHRI-2021
- Conditions
- Bottle Feeding, Premature
- Keywords
- Premature Infant, Bottle Feeding, Side-lying Position, Oral Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Polish Mother Memorial Hospital Research InstituteUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental SLP-R | Experimental | Other: Experimental SLP-RInfant 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) |
| Experimental SLP-L | Experimental | Other: Experimental SLP-LInfant 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). |
Who may qualify
- Ages
- 32 to 38 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental SLP-RSLP-R will be given to the infant during bottle-feeding. | Other | Experimental SLP-R |
| Experimental SLP-LSLP-L will be given to the infant during bottle-feeding. | Other | Experimental SLP-L |
Primary outcome
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
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
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
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.
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
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
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
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna D Raczyńska, PhD principal investigator
Polish Mother's Memorial Hospital - Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental SLP-R and Experimental SLP-L in people with Bottle Feeding and Premature, run by Polish Mother Memorial Hospital Research Institute at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.