Feeding BehaviorNCT02962609
Effect of Feeding Positions of Preterm Infants on Some Physiological Characteristics
A study testing Semielevated Side-lying Position-ESL and Semielevated Supine Position in people with Feeding Behavior, run by Istanbul University.
Trial summary
The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants upon their physiological characteristics and feeding performances. Read more about this study
- Who is it for?
- Ages 32 to 38 weeksHealthy volunteers can take part
- Conditions the study is for
- Feeding Behavior
- What is being tested?
- Semielevated Side-lying Position-ESL and Semielevated Supine Position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- To be born between 26-31+6 gestational weeks according to mother's last menstruation date,
- To be between 32-39+6 postmenstrual weeks during the study,
- Have a body weight above 1500 g,
- Have a full enteral feeding,
- To be in a transition from orogastric catheter feeding to oral feeding for less than 24 hours,
- Have an oral feeding in this process for at least once,
- Tolerate at least 80% of amount of food given lastly during oral feeding,
- Voluntarily signing of the written informed consent form by parents
Who cannot join
- Infants suffering from craniofacial abnormalities like cleft palate,
- cleft lip and facial muscle paralysis; gastrointestinal, neurological and genetic disorders (necrotising enterocolitis, intracranial haemorrhage, periventricular leukomalacia, hydrocephalia, down syndrome, omphalocele, gastroschisis, short bowel syndrome etc.)
- moderate and severe bronchopulmonary dysplasia (BPD) (Jobe \& Bancalari, 2001)
- patent ductus arteriosus requiring surgical therapy were excluded from the study
About this study
Official title: Comparing the Effect of Feeding Preterm Infants in Two Different Positions on Some Physiological Characteristics: A Randomized-Controlled Trial
The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants upon their physiological characteristics and feeding performances.
Read the detailed description
Semielevated supine position (ESU) is a position frequently used in neonatal intensive care units. In this position, infant is laid and fed on its back and the head is elevated to an angle of 45-60° in order to reduce the respiratory load of lungs. The ESL position, head of the infant is elevated to an angle of 45-60° and the infant is fed in the side-lying position. Since this position mimics the breast-feeding position, very preterm infants are supported to utilize the advantages of breast-feeding. A randomization was provided in the sample group consisting of totally 80 infants and while 38 infants were included in the ESL (experimental) group, 42 infants were included in the ESU (control) group.In the power analysis repeated at the end of the study, the power of the study was determined as 87% at a reliability of 95%.
- Conditions
- Feeding Behavior
- Being tested
- Semielevated Side-lying Position-ESL, Semielevated Supine Position
- Keywords
- Feeding, preterm infant, physiological characteristics, position, ESL, ESU
- Medical subject headings
- Feeding Behavior, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semielevated Side-lying Position-ESLOther
The infants in the experimental group (n = 38) were held in the ESL position. In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infantswere held in the side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and their head and neck were held at the same level by the researcher; whereas, their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.
Semielevated Supine PositionOther
The ESU position was applied to the infants in the control group (n=42). In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and they was laid in the supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.
| Study group | Role | What they receive |
|---|---|---|
| Semielevated Side-Lying Position-ESL | Experimental | Preterm infants feed in the ESL position. In the ESL position, infant's head and trunk were elevated to an angle of 45-60° with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infants were held in side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and both the head and the neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor. Receives: Other: Semielevated Side-lying Position-ESL |
| Semielevated Supine Position-ESU | Experimental | Before feeding: In the ESU position, the head and the trunk of the infant were elevated to an angle of 45-60° with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and the infant was laid in supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor. Receives: Other: Semielevated Supine Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Oxygen Saturation
Oxygen saturation were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding.
Measured: During feeding (maximum 30 min)
Secondary outcomes (1)
Heart Rate/Minute During Feeding
Heart rate were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding. Feeding duration, feeding efficiency, and percentage of food intake were evaluated via a video during the feeding and recorded after the feeding.
Measured: During feeding (maximum 30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Feeding BehaviorStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUYGU GOZEN, Istanbul University
- Investigators
- Burcu AYKANAT GİRGİN, Principal investigator, Istanbul University Florence Nightingale Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962609
- Sponsor's protocol ID
- 48252- BAP IU
- Status last verified
- Sep 2019
- First submitted
- 1 Nov 2016
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Feeding Preterm Infants in Two Different Positions on Some Physiological Characteristics: A Randomized-Controlled Trial
- ClinicalTrials.gov ID
- NCT02962609
- Acronym / sponsor ID
- 48252- BAP IU
- Conditions
- Feeding Behavior
- Keywords
- Feeding, preterm infant, physiological characteristics, position, ESL, ESU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of Semielevated Side-Lying (ESL) and Semielevated Supine Position (ESU) positions used in bottle-feeding of very preterm infants upon their physiological characteristics and feeding performances.
Detailed description
Semielevated supine position (ESU) is a position frequently used in neonatal intensive care units. In this position, infant is laid and fed on its back and the head is elevated to an angle of 45-60° in order to reduce the respiratory load of lungs. The ESL position, head of the infant is elevated to an angle of 45-60° and the infant is fed in the side-lying position. Since this position mimics the breast-feeding position, very preterm infants are supported to utilize the advantages of breast-feeding. A randomization was provided in the sample group consisting of totally 80 infants and while 38 infants were included in the ESL (experimental) group, 42 infants were included in the ESU (control) group.In the power analysis repeated at the end of the study, the power of the study was determined as 87% at a reliability of 95%.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semielevated Side-Lying Position-ESL | Experimental | Other: Semielevated Side-lying Position-ESLPreterm infants feed in the ESL position. In the ESL position, infant's head and trunk were elevated to an angle of 45-60° with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infants were held in side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and both the head and the neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor. |
| Semielevated Supine Position-ESU | Experimental | Other: Semielevated Supine PositionBefore feeding: In the ESU position, the head and the trunk of the infant were elevated to an angle of 45-60° with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and the infant was laid in supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas the chin was held in the flexion posture mildly facing the floor. |
Who may qualify
- Ages
- 32 to 38 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- To be born between 26-31+6 gestational weeks according to mother's last menstruation date,
- To be between 32-39+6 postmenstrual weeks during the study,
- Have a body weight above 1500 g,
- Have a full enteral feeding,
- To be in a transition from orogastric catheter feeding to oral feeding for less than 24 hours,
Key exclusion criteria (4 listed)
- Infants suffering from craniofacial abnormalities like cleft palate,
- cleft lip and facial muscle paralysis; gastrointestinal, neurological and genetic disorders (necrotising enterocolitis, intracranial haemorrhage, periventricular leukomalacia, hydrocephalia, down syndrome, omphalocele, gastroschisis, short bowel syndrome etc.)
- moderate and severe bronchopulmonary dysplasia (BPD) (Jobe \& Bancalari, 2001)
- patent ductus arteriosus requiring surgical therapy were excluded from the study
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 |
|---|---|---|
| Semielevated Side-lying Position-ESLThe infants in the experimental group (n = 38) were held in the ESL position. In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infantswere held in the side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and their head and neck were held at the same level by the researcher; whereas, their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand. | Other | Semielevated Side-Lying Position-ESL |
| Semielevated Supine PositionThe ESU position was applied to the infants in the control group (n=42). In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and they was laid in the supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand. | Other | Semielevated Supine Position-ESU |
Primary outcome
Percentage of Oxygen Saturation
Time frame: During feeding (maximum 30 min)
Oxygen saturation were measured by using a pulse oximeter 2 min before the feeding, during the feeding and for 30 min after the feeding.
1 secondary outcome
Heart Rate/Minute During Feeding
Time frame: During feeding (maximum 30 min)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Burcu AYKANAT GİRGİN principal investigator
Istanbul University Florence Nightingale Faculty of Nursing
Questions about this trial
What is this clinical trial studying?
A study testing Semielevated Side-lying Position-ESL and Semielevated Supine Position in people with Feeding Behavior, run by Istanbul University.
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 8 inclusion and 4 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Oxygen Saturation (time frame: During feeding (maximum 30 min)). 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 18 Oct 2019.