Premature BirthNCT02661360
Effects of Swaddling on Infants During Feeding
A study testing Swaddling Intervention for Preterm Infants in people with Premature Birth, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. Results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle… Read more about this study
- Who is it for?
- Ages 1 day and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Swaddling Intervention for Preterm Infants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Apr 2016
- 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 1 day and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all infants born before 34 weeks gestational age will be included as long as they do not have any exclusion criteria
- infants born before 34 weeks gestational age is 33 weeks 3 days to 35 weeks 0 days, with attainment of exclusive bottle feeding at 36 weeks gestational age at the earliest.
- Infants who are multiples will be included but restricted to twins and triplets.
- Infants will only be included if their parents provide informed consent for participation of their infant in the study.
Who cannot join
- The exclusion criteria are factors commonly associated with feeding problems in infants beyond prematurity, including:
- Infants who are exclusively breastfed
- Higher order multiples than twins and triplets (ie. quadruplets)
- Infants with conditions that may affect feeding performance:
- Grades III and IV intraventricular hemorrhage
- Necrotizing enterocolitis
Show all 9Show fewer
- Congenital cardiac anomalies (except medically managed patent ductus arteriosus)
- Genetic syndromes
- Craniofacial abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Effects of Swaddling During Bottle Feeding on Infants Born Preterm
The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. Results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle feeding.
Read the detailed description
Once an infant is orally feeding a minimum of two times per nursing shift for four consecutive nursing shifts, the infant will be randomly assigned to receive the intervention (swaddling) or control condition (no swaddling) first, by the research OT randomly choosing an envelope with the assignment enclosed. The intervention and control feedings for each infant will be consecutive and will take place at the infant's bedside in the NICU. Infants will be assessed at each nursing care time for feeding readiness by the research OT and feeding OT according the policies of the NYU Langone Medical Center NICU, which utilizes the Infant-Driven Feeding Scale-Readiness (Appendix B) (Ludwig \& Waitzman, 2006). When the infant demonstrates readiness, the first condition will be initiated. At the next feeding when the infant demonstrates readiness, the opposite condition will be applied. If the infant is not available due to procedures or not demonstrating feeding readiness, at the next two caregiving times after the first feeding, the infant will be discontinued for that day and will start the study over the next day.
- Conditions
- Premature Birth
- Being tested
- Swaddling Intervention for Preterm Infants, Unswaddled Control
- Keywords
- swaddling
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swaddling Intervention for Preterm InfantsBehavioural
Procedure for swaddling includes folding one corner of the blanket down two thirds of the way down the blanket in order to make the blanket into a triangular shape. The infant will be positioned with shoulders at the fold of the blanket. The infant will be positioned with the blanket so that elbows, hips, and knees flexed with hands near the face by wrapping one side of the blanket across the chest holding the hands in place, pulling the bottom corner up toward the infant's face, and securing the blanket with the last corner pulled across the infant's chest again and around their back. The blanket will be tight enough to keep extremities in place but one finger will be able to be placed between the infant and the blanket.
Unswaddled ControlBehavioural
Procedure for control is blanket loosely draped across the infant without providing containment and without touching the anterior surface of the infant.
| Study group | Role | What they receive |
|---|---|---|
| Starting condition of swaddled | Experimental | Not described Receives: Behavioral: Swaddling Intervention for Preterm Infants; Behavioral: Unswaddled Control |
| Starting Condition of Unswaddled | Experimental | Not described Receives: Behavioral: Swaddling Intervention for Preterm Infants; Behavioral: Unswaddled Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)
Measured: 1 Day
Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)
Measured: 1 Day
Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)
Measured: 1 Day
Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)
Measured: 1 Day
Physiologic stability measured by subtest of Early Feeding Skills Assessment (EFS)
Stability of heart rate and respiratory rate are indicative of the ability of the infant born preterm to cope with stress during bottle feeding
Measured: 1 Day
Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)
Measured: 1 Day
Number of significant changes in heart rate (bradycardia
Measured: 1 Day
Number of significant oxygen desaturations
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Vanlew, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661360
- Sponsor's protocol ID
- 15-00493
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2016
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Swaddling During Bottle Feeding on Infants Born Preterm
- ClinicalTrials.gov ID
- NCT02661360
- Acronym / sponsor ID
- 15-00493
- Conditions
- Premature Birth
- Keywords
- swaddling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 22 Jan 2016 (estimated)
- 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.
The purpose of this randomized, within-subject, cross-over study is to examine if swaddling affects bottle feeding performance in infants born preterm. Results from research will have implication on neurobehavioral and physiologic outcomes as important indicators for the possible effect of swaddling during bottle feeding.
Detailed description
Once an infant is orally feeding a minimum of two times per nursing shift for four consecutive nursing shifts, the infant will be randomly assigned to receive the intervention (swaddling) or control condition (no swaddling) first, by the research OT randomly choosing an envelope with the assignment enclosed. The intervention and control feedings for each infant will be consecutive and will take place at the infant's bedside in the NICU. Infants will be assessed at each nursing care time for feeding readiness by the research OT and feeding OT according the policies of the NYU Langone Medical Center NICU, which utilizes the Infant-Driven Feeding Scale-Readiness (Appendix B) (Ludwig \& Waitzman, 2006). When the infant demonstrates readiness, the first condition will be initiated. At the next feeding when the infant demonstrates readiness, the opposite condition will be applied. If the infant is not available due to procedures or not demonstrating feeding readiness, at the next two caregiving times after the first feeding, the infant will be discontinued for that day and will start the study over the next day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starting condition of swaddled | Experimental | Behavioral: Swaddling Intervention for Preterm Infants, Behavioral: Unswaddled Control |
| Starting Condition of Unswaddled | Experimental | Behavioral: Swaddling Intervention for Preterm Infants, Behavioral: Unswaddled Control |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- all infants born before 34 weeks gestational age will be included as long as they do not have any exclusion criteria
- infants born before 34 weeks gestational age is 33 weeks 3 days to 35 weeks 0 days, with attainment of exclusive bottle feeding at 36 weeks gestational age at the earliest.
- Infants who are multiples will be included but restricted to twins and triplets.
- Infants will only be included if their parents provide informed consent for participation of their infant in the study.
Key exclusion criteria (9 listed)
- The exclusion criteria are factors commonly associated with feeding problems in infants beyond prematurity, including:
- Infants who are exclusively breastfed
- Higher order multiples than twins and triplets (ie. quadruplets)
- Infants with conditions that may affect feeding performance:
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 |
|---|---|---|
| Swaddling Intervention for Preterm InfantsProcedure for swaddling includes folding one corner of the blanket down two thirds of the way down the blanket in order to make the blanket into a triangular shape. The infant will be positioned with shoulders at the fold of the blanket. The infant will be positioned with the blanket so that elbows, hips, and knees flexed with hands near the face by wrapping one side of the blanket across the chest holding the hands in place, pulling the bottom corner up toward the infant's face, and securing the blanket with the last corner pulled across the infant's chest again and around their back. The blanket will be tight enough to keep extremities in place but one finger will be able to be placed between the infant and the blanket. | Behavioural | Starting Condition of Unswaddled, Starting condition of swaddled |
| Unswaddled ControlProcedure for control is blanket loosely draped across the infant without providing containment and without touching the anterior surface of the infant. | Behavioural | Starting Condition of Unswaddled, Starting condition of swaddled |
Primary outcome
Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS)
Time frame: 1 Day
Feeding engagement measured by subtest of Early Feeding Skills Assessment (EFS)
Time frame: 1 Day
Oral motor organization measured by subtest of Early Feeding Skills Assessment (EFS)
Time frame: 1 Day
Swallow coordination measured by subtest of Early Feeding Skills Assessment (EFS)
Time frame: 1 Day
Physiologic stability measured by subtest of Early Feeding Skills Assessment (EFS)
Time frame: 1 Day
Stability of heart rate and respiratory rate are indicative of the ability of the infant born preterm to cope with stress during bottle feeding
Feeding recovery measured by subtest of Early Feeding Skills Assessment (EFS)
Time frame: 1 Day
Number of significant changes in heart rate (bradycardia
Time frame: 1 Day
Number of significant oxygen desaturations
Time frame: 1 Day
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 27 Jan 2017.
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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.
Steve Vanlew, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swaddling Intervention for Preterm Infants in people with Premature Birth, run by NYU Langone Health at 1 site in United States.
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 4 inclusion and 9 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 27 Jan 2017. 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 United States. 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?
Oral feeding readiness measured by subtest of Early Feeding Skills Assessment (EFS) (time frame: 1 Day). The study lists 8 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 27 Jan 2017.