PrematurityP-NAT-BIONCT05030233
Pilot Study of Nursing Touch and Biobehavioral Stress
A study testing Nurse-Administered Touch Intervention in people with Prematurity and Stress Reaction, run by Ohio State University at 1 site in United States.
Trial summary
Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit. Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Prematurity, Stress Reaction
- What is being tested?
- Nurse-Administered Touch Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 17 May 2022
- 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 Up to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born prematurely between 27 and 30 weeks post-menstrual age.
- Born to mothers who are English-speaking and able to provide informed consent.
- No more than 10 days old at the time of enrollment.
Who cannot join
- Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.
- Diagnosed with a congenital anomaly requiring surgery during the neonatal period.
- Receiving scheduled steroids or vasopressors.
- Skin conditions that preclude the attachment of sensors.
- Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.
- Diagnosed with chromosomal abnormalities.
- Requiring special isolation with universal gloving for potentially infectious pathogens.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants
Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.
Read the detailed description
Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.
- Conditions
- Prematurity, Stress Reaction
- Being tested
- Nurse-Administered Touch Intervention
- Keywords
- preterm infant, stress, nursing care, touch
- Medical subject headings
- Premature Birth, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Administered Touch InterventionBehavioural
The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
| Study group | Role | What they receive |
|---|---|---|
| Nurse-Administered Touch Intervention | Experimental | Preterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care. Receives: Behavioral: Nurse-Administered Touch Intervention |
| Standard Care | No intervention | Preterm infants will receive one episode of essential nursing care delivered as standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Heart Rate -- During Intervention
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Measured: during intervention or control period, approximately 20 minutes
Average Heart Rate -- Recovery
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Measured: recovery, 30 minutes after intervention delivery or control period
Secondary outcomes (4)
Average High-frequency Heart Rate Variability -- During Caregiving Episode
Spectral analysis of high-frequency heart rate variability averaged over the episode of caregiving during which infants received either the nurse-administered touch intervention or standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Measured: during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes
Average High-frequency Heart Rate Variability -- Recovery
Spectral analysis of high-frequency heart rate variability averaged over the 30-minute period following caregiving that included the nurse-administered touch intervention or was delivered as standard care. Spectral analysis of the high frequency band is a non-linear measure of heart rate variability that quantifies, primarily, parasympathetic nervous system (vagal) tone.
Measured: recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care
Average Frequency of Skin Conductance Responses -- During Caregiving Episode
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the caregiving episode that includes either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of caregiving.
Measured: during caregiving episode, approximately 20 minutes
Average Frequency of Skin Conductance Responses -- Recovery
Frequency of skin conductance responses will be measured using an external monitor with electrodes attached to the infant's foot and averaged over the 30-minute period following the caregiving episode that included either the nurse-administered touch intervention or standard care. Frequency is measured as number of waves per second over the duration of the 30-minute recovery period.
Measured: recovery, 30 minutes after intervention delivery or control period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start10 Sep 2021
- Primary completion20 Apr 2022
- Study completion17 May 2022
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 PrematurityStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized cross-over design
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Marliese Nist, Ohio State University
- Investigators
- Marliese D. Nist, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030233
- Sponsor's protocol ID
- 2021N0006
- Acronym
- P-NAT-BIO
- Status last verified
- Jan 2025
- First submitted
- 23 Aug 2021
- Last updated
- 18 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants
- ClinicalTrials.gov ID
- NCT05030233
- Acronym / sponsor ID
- P-NAT-BIO / 2021N0006
- Conditions
- Prematurity, Stress Reaction
- Keywords
- preterm infant, stress, nursing care, touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Posted 18 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.
Detailed description
Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized cross-over design
| Arm | Type | Receives |
|---|---|---|
| Nurse-Administered Touch Intervention | Experimental | Behavioral: Nurse-Administered Touch InterventionPreterm infants will receive the nurse-administered touch intervention during one episode of essential nursing care. |
| Standard Care | No intervention | –Preterm infants will receive one episode of essential nursing care delivered as standard care. |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born prematurely between 27 and 30 weeks post-menstrual age.
- Born to mothers who are English-speaking and able to provide informed consent.
- No more than 10 days old at the time of enrollment.
Key exclusion criteria (7 listed)
- Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.
- Diagnosed with a congenital anomaly requiring surgery during the neonatal period.
- Receiving scheduled steroids or vasopressors.
- Skin conditions that preclude the attachment of sensors.
- Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.
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 |
|---|---|---|
| Nurse-Administered Touch InterventionThe nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode. | Behavioural | Nurse-Administered Touch Intervention |
Primary outcome
Average Heart Rate -- During Intervention
Time frame: during intervention or control period, approximately 20 minutes
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Average Heart Rate -- Recovery
Time frame: recovery, 30 minutes after intervention delivery or control period
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
4 secondary outcomes
Average High-frequency Heart Rate Variability -- During Caregiving Episode
Time frame: during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes
Average High-frequency Heart Rate Variability -- Recovery
Time frame: recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care
Average Frequency of Skin Conductance Responses -- During Caregiving Episode
Time frame: during caregiving episode, approximately 20 minutes
Average Frequency of Skin Conductance Responses -- Recovery
Time frame: recovery, 30 minutes after intervention delivery or control period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- 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.
Marliese D. Nist, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Administered Touch Intervention in people with Prematurity and Stress Reaction, run by Ohio State University 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 3 inclusion and 7 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 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2025). 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?
Average Heart Rate -- During Intervention (time frame: during intervention or control period, approximately 20 minutes). The study lists 2 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 18 Feb 2025.