Extreme PrematurityNCT04652063
Osteopathic Manipulative Medicine to Reduce Developmental Delays
A study testing Osteopathic Manipulative Medicine in people with Extreme Prematurity and Neurodevelopmental Abnormality, run by University of Rochester at 2 sites in United States.
Trial summary
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP). Read more about this study
- Who is it for?
- Ages 1 day to 14 weeksHealthy volunteers can take part
- Conditions the study is for
- Extreme Prematurity, Neurodevelopmental Abnormality
- What is being tested?
- Osteopathic Manipulative Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jan 2021to 30 Jul 2023
- 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 to 14 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 23 0/7- 33 6/7 weeks' gestational age (GA) at birth, ≥28 0/7 weeks' GA at time of consent
- stable enough to tolerate gentle manipulation
Who cannot join
- > 33 6/7 weeks' GA at birth
- known congenital and genetic abnormalities affecting neurodevelopment
- known conditions requiring surgical intervention
- severe intracranial hemorrhage or other severe neurologic complications
- parents unable to read and understand English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Golisano Children's Hospital
Rochester, New York, 14642
University of Rochester
Rochester, New York, 14642
About this study
Official title: Using Osteopathic Manipulative Medicine on Preterm Infants in the Neonatal Intensive Care Unit to Reduce Neuromotor Developmental Delays
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
Read the detailed description
Hypothesis: High risk preterm infants born <34 weeks of gestation who receive OMM, compared to the standard supportive care, will have improved neuromotor development scores on the TIMP.
Specific Aims and Objectives:
Primary aim: To determine the difference in TIMP scores between infants who receive OMM and those who receive only standard neonatal intensive care unit (NICU) care.
Secondary aims:
- To compare length of stay between infants who receive OMM and those who receive only standard NICU care.
- To compare growth parameters including weight, length, and head circumference, (both means and Z scores) prior to discharge between infants who receive OMM and those who receive only standard NICU care.
- To compare percentage of subjects requiring nasogastric, orogastric, or gastrostomy tube feeds at discharge between infants who receive OMM and those who receive only standard NICU care.
- Being tested
- Osteopathic Manipulative Medicine
- Keywords
- osteopathic manipulative medicine (OMM), test of infant motor performance (TIMP), neurodevelopmental outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative MedicineOther
Osteopathic evaluation and treatment (gentle touch according to published protocols) will take about 15 - 20 minutes, and will be performed every 7 - 10 days during the infant's NICU stay once they reach at minimum of at least 28 weeks corrected gestational age and until they reach 36 weeks corrected gestational age.
| Study group | Role | What they receive |
|---|---|---|
| OMM | Experimental | Neonates randomized to receive osteopathic manipulation Receives: Other: Osteopathic Manipulative Medicine |
| Control | No intervention | Neonates randomized to receive standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test of Infant Motor Performance (TIMP)
Standardized, validated assessment of risk for developmental delay; expected range: 20 - 90 with higher scores indicating less risk for developmental delay
Measured: At approximately 36 weeks' corrected gestational age
Secondary outcomes (5)
Length of stay
Number of days in Neonatal Intensive Care Unit (NICU)
Measured: At NICU discharge, assessed up to 1 year
Growth parameters - weight
weight z-score
Measured: at 36 weeks' corrected gestational age and discharge
Growth parameters - length
length z-score
Measured: at 36 weeks' corrected gestational age and discharge
Growth parameters - head circumference
head circumference z-score
Measured: at 36 weeks' corrected gestational age and discharge
Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge
Number of neonates requiring NG, OG, or gastrostomy feeds at discharge from NICU
Measured: at NICU discharge, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start5 Jan 2021
- Primary completion1 Dec 2022
- Study completion30 Jul 2023
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 Extreme PrematurityStudies 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
- Parallel groups
- Model description
- Randomization 1:1 to control and intervention group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronnie Guillet, University of Rochester
- Investigators
- Ronnie Guillet, MD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652063
- Sponsor's protocol ID
- Study00005304
- Status last verified
- Aug 2023
- First submitted
- 25 Nov 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share HPI and data for individual participants at this time.
Publications
Cerritelli F, Martelli M, Renzetti C, Pizzolorusso G, Cozzolino V, Barlafante G. Introducing an osteopathic approach into neonatology ward: the NE-O model. Chiropr Man Therap. 2014 May 9;22:18. doi: 10.1186/2045-709X-22-18. eCollection 2014.
PubMed 24904746Wang L, He JL, Zhang XH. The efficacy of massage on preterm infants: a meta-analysis. Am J Perinatol. 2013 Oct;30(9):731-8. doi: 10.1055/s-0032-1332801. Epub 2013 Jan 15.
PubMed 23322391Cerritelli F, Pizzolorusso G, Renzetti C, Cozzolino V, D'Orazio M, Lupacchini M, Marinelli B, Accorsi A, Lucci C, Lancellotti J, Ballabio S, Castelli C, Molteni D, Besana R, Tubaldi L, Perri FP, Fusilli P, D'Incecco C, Barlafante G. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms. PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015.
PubMed 25974071Campbell SK, Swanlund A, Smith E, Liao PJ, Zawacki L. Validity of the TIMPSI for estimating concurrent performance on the test of infant motor performance. Pediatr Phys Ther. 2008 Spring;20(1):3-10. doi: 10.1097/PEP.0b013e31815f66a6.
PubMed 18300928
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Osteopathic Manipulative Medicine on Preterm Infants in the Neonatal Intensive Care Unit to Reduce Neuromotor Developmental Delays
- ClinicalTrials.gov ID
- NCT04652063
- Acronym / sponsor ID
- Study00005304
- Keywords
- osteopathic manipulative medicine (OMM), test of infant motor performance (TIMP), neurodevelopmental outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 3 Dec 2020 (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.
This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM) increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of Infant Motor Performance (TIMP).
Detailed description
Hypothesis: High risk preterm infants born <34 weeks of gestation who receive OMM, compared to the standard supportive care, will have improved neuromotor development scores on the TIMP.
Specific Aims and Objectives:
Primary aim: To determine the difference in TIMP scores between infants who receive OMM and those who receive only standard neonatal intensive care unit (NICU) care.
Secondary aims:
- To compare length of stay between infants who receive OMM and those who receive only standard NICU care.
- To compare growth parameters including weight, length, and head circumference, (both means and Z scores) prior to discharge between infants who receive OMM and those who receive only standard NICU care.
- To compare percentage of subjects requiring nasogastric, orogastric, or gastrostomy tube feeds at discharge between infants who receive OMM and those who receive only standard NICU care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization 1:1 to control and intervention group
| Arm | Type | Receives |
|---|---|---|
| OMM | Experimental | Other: Osteopathic Manipulative MedicineNeonates randomized to receive osteopathic manipulation |
| Control | No intervention | –Neonates randomized to receive standard care only |
Who may qualify
- Ages
- 1 day to 14 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 23 0/7- 33 6/7 weeks' gestational age (GA) at birth, ≥28 0/7 weeks' GA at time of consent
- stable enough to tolerate gentle manipulation
Key exclusion criteria (5 listed)
- > 33 6/7 weeks' GA at birth
- known congenital and genetic abnormalities affecting neurodevelopment
- known conditions requiring surgical intervention
- severe intracranial hemorrhage or other severe neurologic complications
- parents unable to read and understand English
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 |
|---|---|---|
| Osteopathic Manipulative MedicineOsteopathic evaluation and treatment (gentle touch according to published protocols) will take about 15 - 20 minutes, and will be performed every 7 - 10 days during the infant's NICU stay once they reach at minimum of at least 28 weeks corrected gestational age and until they reach 36 weeks corrected gestational age. | Other | OMM |
Primary outcome
Test of Infant Motor Performance (TIMP)
Time frame: At approximately 36 weeks' corrected gestational age
Standardized, validated assessment of risk for developmental delay; expected range: 20 - 90 with higher scores indicating less risk for developmental delay
5 secondary outcomes
Length of stay
Time frame: At NICU discharge, assessed up to 1 year
Growth parameters - weight
Time frame: at 36 weeks' corrected gestational age and discharge
Growth parameters - length
Time frame: at 36 weeks' corrected gestational age and discharge
Growth parameters - head circumference
Time frame: at 36 weeks' corrected gestational age and discharge
Need for nasogastric (NG), orogastric (OG), or gastrostomy tube feeds at discharge
Time frame: at NICU discharge, assessed up to 1 year
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 14 Aug 2023.
- Background: PubMed 24904746Cerritelli F, Martelli M, Renzetti C, Pizzolorusso G, Cozzolino V, Barlafante G. Introducing an osteopathic approach into neonatology ward: the NE-O model. Chiropr Man Therap. 2014 May 9;22:18. doi: 10.1186/2045-709X-22-18. eCollection 2014.
- Background: PubMed 23322391Wang L, He JL, Zhang XH. The efficacy of massage on preterm infants: a meta-analysis. Am J Perinatol. 2013 Oct;30(9):731-8. doi: 10.1055/s-0032-1332801. Epub 2013 Jan 15.
- Background: PubMed 25974071Cerritelli F, Pizzolorusso G, Renzetti C, Cozzolino V, D'Orazio M, Lupacchini M, Marinelli B, Accorsi A, Lucci C, Lancellotti J, Ballabio S, Castelli C, Molteni D, Besana R, Tubaldi L, Perri FP, Fusilli P, D'Incecco C, Barlafante G. A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms. PLoS One. 2015 May 14;10(5):e0127370. doi: 10.1371/journal.pone.0127370. eCollection 2015.
- Background: PubMed 18300928Campbell SK, Swanlund A, Smith E, Liao PJ, Zawacki L. Validity of the TIMPSI for estimating concurrent performance on the test of infant motor performance. Pediatr Phys Ther. 2008 Spring;20(1):3-10. doi: 10.1097/PEP.0b013e31815f66a6.
- Individual participant dataSharing planned: No. No plans to share HPI and data for individual participants at this time.
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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.
Ronnie Guillet, MD, PhD principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Medicine in people with Extreme Prematurity and Neurodevelopmental Abnormality, run by University of Rochester at 2 sites 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 2 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 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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) (time frame: At approximately 36 weeks' corrected gestational age). 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 NCT04652063, 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 14 Aug 2023.