Premature BirthNCT03759119
Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm
A study testing Tummy time and parent education and Parent education only in people with Premature Birth, run by University of Indianapolis at 1 site in United States.
Trial summary
The purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. Participants will be recruited from Ann and Robert H. Lurie Children's Hospital of Chicago neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages 35 to 44 weeks
- Conditions the study is for
- Premature Birth
- What is being tested?
- Tummy time and parent education and Parent education only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 23 Mar 2020
- 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 35 to 44 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be eligible to participate in the study, participants must meet the following inclusion criteria:
- born premature (< 37 weeks' gestation),
- require medical care within Lurie Children's NICU, be between 35 and 44 weeks postmenstrual age.
- Primary parent must have a working mobile device.
- Participants must be English or Spanish speaking as primary language.
Who cannot join
- primary parent does not having a working mobile device and
- Speaking a language other than English or Spanish.
- Unable to be placed in the prone position,
- Physiologically unstable for handling
- Orally intubated or have a tracheostomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: a Randomized Control Trial
The purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. Participants will be recruited from Ann and Robert H. Lurie Children's Hospital of Chicago neonatal intensive care unit.
Read the detailed description
The purpose of this randomized control trial will be to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week period. Additionally, the study will measure tummy time adherence rates between groups post intervention for an additional four weeks.
To meet this purpose, the following objectives will be addressed:
- To determine if there will be a difference in motor outcome scores on the Test of Infant Motor Performance (TIMP) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.
- To determine if there will be a difference in adherence rates (average minutes/day) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.
- Conditions
- Premature Birth
- Being tested
- Tummy time and parent education, Parent education only
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tummy time and parent educationBehavioural
Also called Group 1
Participants will receive tummy time positioning while awake for 10 minutes two times a day. Physiological monitoring will be maintained throughout the entire intervention and the intervention will be adjusted if needed to maintain stability. Participants will also receive parent education on tummy time prior to the tummy time intervention. The primary investigator will perform the tummy time intervention. Participants will be encouraged to continue performing tummy time on their own and record their adherence via the PT Pal application.
Parent education onlyBehavioural
Also called Group 2
Participants will receive the same tummy time education as those in the intervention group and will be asked to continue the intervention on their own and record their adherence via the PT Pal application.
Steps of the intervention for group 2 (standard care).
- Complete educational session with primary investigator.
- Adherence during the four-week intervention period will be measured remotely through the PT Pal® application.
| Study group | Role | What they receive |
|---|---|---|
| Tummy Time and Parent Education | Experimental | This group will receive tummy time and parent education and be encouraged to perform tummy time on their own. They will utilize the PT Pal application to record their tummy time adherence. The primary investigator performs the intervention to the participants two times a day for 10 minutes for 4 weeks. Receives: Behavioral: Tummy time and parent education; Behavioral: Parent education only |
| Parent education | No intervention | This group will receive parent education only and utilize the PT Pal application to record their adherence. The primary caregiver will be encouraged to perform the same dosage of tummy time (2x/day, 10 minutes each, 4 weeks) and record their adherence on the PT Pal application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Infant Motor Performance (TIMP) for motor outcome
The TIMP is a functional motor scale for newborns, including those born premature, up to infants four months corrected age, and was specifically designed for use in neonatal intensive care units (Rose \& Westcott, 2005).
Measured: Change in motor outcome will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.
Secondary outcomes (1)
PT Pal Application: Adherence
The PT Pal application will be utilized to generate information back to the PI on adherence with tummy time outcomes of the prescription recommendations and thus serves as an adherence component for both the intervention and the standard care group.
Measured: Change in adherence will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start6 Feb 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized controlled trial using a pretest /posttest control group design to allow for comparison between an intervention group that receives tummy time and parent education and a standard of care group that receives parent education only
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Indianapolis
- Sponsor type
- University, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Kathryn Martin, University of Indianapolis
- Investigators
- Kathy Martin, DHSc, Study chair, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759119
- Sponsor's protocol ID
- 2018-2239
- Status last verified
- Mar 2020
- First submitted
- 20 Nov 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bentzley JP, Coker-Bolt P, Moreau NG, Hope K, Ramakrishnan V, Brown T, Mulvihill D, Jenkins D. Kinematic measurement of 12-week head control correlates with 12-month neurodevelopment in preterm infants. Early Hum Dev. 2015 Feb;91(2):159-64. doi: 10.1016/j.earlhumdev.2015.01.001. Epub 2015 Jan 23.
PubMed 25621433Campbell SK, Hedeker D. Validity of the Test of Infant Motor Performance for discriminating among infants with varying risk for poor motor outcome. J Pediatr. 2001 Oct;139(4):546-51. doi: 10.1067/mpd.2001.117581.
PubMed 11598602Lekskulchai R, Cole J. Effect of a developmental program on motor performance in infants born preterm. Aust J Physiother. 2001;47(3):169-76. doi: 10.1016/s0004-9514(14)60264-6.
PubMed 11552873Oberg GK, Campbell SK, Girolami GL, Ustad T, Jorgensen L, Kaaresen PI. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences. BMC Pediatr. 2012 Feb 15;12:15. doi: 10.1186/1471-2431-12-15.
PubMed 22336194
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03759119
- Acronym / sponsor ID
- 2018-2239
- Conditions
- Premature Birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of IndianapolisUniversity, hospital or other
- Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 29 Nov 2018 (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.
The purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. Participants will be recruited from Ann and Robert H. Lurie Children's Hospital of Chicago neonatal intensive care unit.
Detailed description
The purpose of this randomized control trial will be to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week period. Additionally, the study will measure tummy time adherence rates between groups post intervention for an additional four weeks.
To meet this purpose, the following objectives will be addressed:
- To determine if there will be a difference in motor outcome scores on the Test of Infant Motor Performance (TIMP) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.
- To determine if there will be a difference in adherence rates (average minutes/day) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This will be a randomized controlled trial using a pretest /posttest control group design to allow for comparison between an intervention group that receives tummy time and parent education and a standard of care group that receives parent education only
| Arm | Type | Receives |
|---|---|---|
| Tummy Time and Parent Education | Experimental | Behavioral: Tummy time and parent education, Behavioral: Parent education onlyThis group will receive tummy time and parent education and be encouraged to perform tummy time on their own. They will utilize the PT Pal application to record their tummy time adherence. The primary investigator performs the intervention to the participants two times a day for 10 minutes for 4 weeks. |
| Parent education | No intervention | –This group will receive parent education only and utilize the PT Pal application to record their adherence. The primary caregiver will be encouraged to perform the same dosage of tummy time (2x/day, 10 minutes each, 4 weeks) and record their adherence on the PT Pal application. |
Who may qualify
- Ages
- 35 to 44 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- To be eligible to participate in the study, participants must meet the following inclusion criteria:
- born premature (< 37 weeks' gestation),
- require medical care within Lurie Children's NICU, be between 35 and 44 weeks postmenstrual age.
- Primary parent must have a working mobile device.
- Participants must be English or Spanish speaking as primary language.
Key exclusion criteria (5 listed)
- primary parent does not having a working mobile device and
- Speaking a language other than English or Spanish.
- Unable to be placed in the prone position,
- Physiologically unstable for handling
- Orally intubated or have a tracheostomy
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 |
|---|---|---|
| Tummy time and parent educationAlso: Group 1Participants will receive tummy time positioning while awake for 10 minutes two times a day. Physiological monitoring will be maintained throughout the entire intervention and the intervention will be adjusted if needed to maintain stability. Participants will also receive parent education on tummy time prior to the tummy time intervention. The primary investigator will perform the tummy time intervention. Participants will be encouraged to continue performing tummy time on their own and record their adherence via the PT Pal application. | Behavioural | Tummy Time and Parent Education |
| Parent education onlyAlso: Group 2Participants will receive the same tummy time education as those in the intervention group and will be asked to continue the intervention on their own and record their adherence via the PT Pal application. Steps of the intervention for group 2 (standard care). * Complete educational session with primary investigator. * Adherence during the four-week intervention period will be measured remotely through the PT Pal® application. | Behavioural | Tummy Time and Parent Education |
Primary outcome
Test of Infant Motor Performance (TIMP) for motor outcome
Time frame: Change in motor outcome will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.
The TIMP is a functional motor scale for newborns, including those born premature, up to infants four months corrected age, and was specifically designed for use in neonatal intensive care units (Rose \& Westcott, 2005).
1 secondary outcome
PT Pal Application: Adherence
Time frame: Change in adherence will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.
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 24 Mar 2020.
- Background: PubMed 25621433Bentzley JP, Coker-Bolt P, Moreau NG, Hope K, Ramakrishnan V, Brown T, Mulvihill D, Jenkins D. Kinematic measurement of 12-week head control correlates with 12-month neurodevelopment in preterm infants. Early Hum Dev. 2015 Feb;91(2):159-64. doi: 10.1016/j.earlhumdev.2015.01.001. Epub 2015 Jan 23.
- Background: PubMed 11598602Campbell SK, Hedeker D. Validity of the Test of Infant Motor Performance for discriminating among infants with varying risk for poor motor outcome. J Pediatr. 2001 Oct;139(4):546-51. doi: 10.1067/mpd.2001.117581.
- Background: PubMed 11552873Lekskulchai R, Cole J. Effect of a developmental program on motor performance in infants born preterm. Aust J Physiother. 2001;47(3):169-76. doi: 10.1016/s0004-9514(14)60264-6.
- Background: PubMed 22336194Oberg GK, Campbell SK, Girolami GL, Ustad T, Jorgensen L, Kaaresen PI. Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences. BMC Pediatr. 2012 Feb 15;12:15. doi: 10.1186/1471-2431-12-15.
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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.
Kathy Martin, DHSc study chair
University of Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tummy time and parent education and Parent education only in people with Premature Birth, run by University of Indianapolis 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 5 inclusion and 5 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 24 Mar 2020. 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?
Test of Infant Motor Performance (TIMP) for motor outcome (time frame: Change in motor outcome will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759119, which also lists 4 linked publications.
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 24 Mar 2020.