Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family ChoiceEarly Phase 1NCT07142564
Carrier Care: An Innovative Approach to Support Small Babies in the NICU
A Early Phase 1 study testing Carrier Care (CC) in people with Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family Choice and Group 2: Skin-to-Skin Care (SSC) Followed by Carrier Care (CC) Followed by Family Choice, run by University of Arizona.
Trial summary
The significance of skin-to-skin care (SSC) for neonatal infants is well-documented, highlighting its benefits for both the infant and the caregiver. The World Health Organization (WHO) has emphasized the necessity of positioning the infant on the mother after birth in a manner to prevent Sudden Unexpected Postnatal… Read more about this study
- Who is it for?
- Ages Up to 9 months
- Conditions the study is for
- Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family Choice, Group 2: Skin-to-Skin Care (SSC) Followed by Carrier Care (CC) Followed by Family Choice
- What is being tested?
- Carrier Care (CC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates who:
- are admitted to the hospital
- who have an estimated length of stay equal to or greater than fifteen (15) days
- weighing greater than or equal to 1800 grams at the time of enrollment
- that are medically stable (free of significant apnea, bradycardia, or desaturations) within the past 48 hours
Who cannot join
- infants who require oxygen therapy or positive pressure respiratory support
- infants who have central intravenous lines (e.g., Broviac or peripherally inserted central catheter)
- caregivers who are prisoners
- caregivers who cannot read or speak English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The significance of skin-to-skin care (SSC) for neonatal infants is well-documented, highlighting its benefits for both the infant and the caregiver. The World Health Organization (WHO) has emphasized the necessity of positioning the infant on the mother after birth in a manner to prevent Sudden Unexpected Postnatal Collapse (SUPC) and accidental drops and falls. SSC is also recommended for 8 hours a day for the first few weeks of life to promote a secure attachment in the infant and bonding with the caregiver.
Despite these established benefits, some families hesitate to engage in skin-to-skin care (SSC) because it is often only done in private settings and requires the caregiver to use their arms to hold the infant in place. Babywearing, or holding the infant to the body of the caregiver using a cloth or infant carrying device, can promote prolonged contact between the caregiver and infant without requiring the caregiver to hold the infant in place with their arms. Babywearing can also be done in more public settings (e.g., grocery store) as the caregiver can remain clothed during babywearing. The purpose of this study is to investigate whether babywearing using a babywearing device, referred to in this study as Carrier Care (CC), is at least as feasible and effective as SSC. This research will evaluate several physiological parameters of the infant, including cardiorespiratory stability, thermoregulation, and oxygen saturation levels. Certified babywearing educators will instruct research participants to ensure proper use of baby carriers and the safety of infants as outlined by the current hospital policy for babywearing.
This study will utilize an amplitude-integrated electroencephalogram (aEEG), a non-invasive, bedside monitoring tool commonly used in neonatal intensive care units (NICUs) to assess brain activity, particularly in premature infants. The aEEG provides a simplified and continuous recording of cortical activity, offering valuable insights into neurological development, including sleep-wake cycling. In this study, the aEEG will be used to evaluate the presence of sleep-wake patterns as a proxy for brain maturation. Data will be collected by placing EEG electrodes on the infant for a total duration of 12 hours: 4 hours prior to the intervention (baseline), 4 hours during the intervention (defined as skin-to-skin contact or carrier care), and 4 hours post-intervention. Recordings will occur on day 3 of the randomized activity to assess potential changes in brain activity associated with the intervention during this critical period of neurodevelopment. Dau 4 or 5 will be used as backup.
Read the detailed description
A large body of research on skin-to-skin contact (SSC), particularly for preterm infants, provides robust evidence that it benefits both mothers and infants (Koreti \& Muntode Gharde, 2022). Premature infants in the NICU are often separated from their caregivers and placed into an otherwise artificial environment, leading to neurological, sociological, and psychological consequences, along with the impacts of being born prematurely. In addition to positive outcomes, it is notable that SSC is a safe intervention. For example, one review found no negative impact on vital signs or any reports of adverse events before, during, or after SSC (Bisanalli et al., 2023). Overall, SSC shortens hospital stays in the NICU, lowers risks for neonatal infection, increases weight gain, lowers cortisol levels, increases feeding tolerance, and helps with thermoregulation and homeostasis while being safe for the infants and their caregivers participating (Azevedo et al., 2012; Cristóbal Cañadas et al., 2022).
Research on babywearing (close physical contact while clothed or extended arms-free holding) is growing, but a recent scoping review indicates positive biological and behavioral effects for both mothers and infants (Grisham et al., 2023). This research team has previously demonstrated that babywearing effectively increases infant and caregiver comfort among infants diagnosed with Neonatal Abstinence Syndrome (Williams et al., 2020). We recently replicated this finding (Rankin et al., 2024), and also found that babywearing was perceived by nurses as helpful in the care and treatment of these infants (Williams et al., 2021). From the caregiver's perspective, babywearing helps with the tasks of parenting (e.g., calming the infant, putting the infant to sleep), increases bonding time, and is convenient (i.e., provides hands-free to complete other tasks) (Williams, 2020). Our research question is guided by the perspective that if babywearing can closely approximate the benefits of SSC, it would provide a more comfortable and convenient alternative to SSC and potentially extend the benefits by allowing for a greater amount of time spent in close physical proximity.
This project investigates the application of amplitude-integrated electro-encephalography (aEEG) to monitor brain activity and sleep-wake cycling in premature and term neonates in NICU settings. Continuous EEG monitoring for at least 2-3 hours is essential to capture both wakefulness and all stages of sleep. It typically utilizes a compressed display to evaluate slow activity and asynchronies critical in neonatal recordings (Mizrahi \& Kellaway, 2017). The aEEG provides a simplified, bedside tool for long-term monitoring of cerebral function, allowing detection of seizures and assessment of background brain activity patterns (Hellström-Westas et al., 2006) (Shellhaas et al., 2023). aEEG has proven especially useful in neonates with seizures, offering early prediction of neurodevelopmental outcomes based on patterns observed within the first 24 hours after birth (Shellhaas et al., 2023). The early presence of sleep-wake cyclicity on aEEG strongly predicts favorable brain imaging outcomes, while delayed or absent cyclicity is associated with severe abnormalities (Bruns et al., 2017).
Preterm infants show altered sleep patterns compared to term infants, with shorter sleep cycles and increased REM sleep, both of which are essential for brain maturation (Bandyopadhyay et al., 2017). Disrupted or insufficient sleep in NICU infants has been linked to short-term physiological alterations and long-term developmental delays, reinforcing the importance of protecting and promoting sleep quality (Gale et al., 2012; Gertner et al., 2012). aEEG is safe, well-tolerated even by extremely preterm infants, and can be interpreted by neonatal staff due to its simplicity and strong interrater reliability (Hellström-Westas et al., 2006; Toet et al., 2006). This research supports the advancement of non-invasive, accessible neuro-monitoring to guide care and improve neurodevelopmental outcomes in high-risk neonatal populations.
Inclusion Criteria for Infants
Participants for this study will include neonates:
- admitted to the hospital
- who have an estimated length of stay equal to or greater than fifteen (15) days
- weighing greater than or equal to 1800 grams at the time of enrollment
- that are medically stable (free of significant apnea, bradycardia, or desaturations) within the past 48 hours
Inclusion Criteria for Caregivers
Caregivers of infant participants for this study will include:
- caregivers must be 18 years or older,
- those willing to comply with the study protocol, specifically to participate daily in carrier care (CC) and skin-to-skin care (SSC) for fifteen (15) consecutive days.
Exclusion Criteria for Infants and Caregivers
Study participants who will be excluded from this study include:
- infants who require oxygen therapy or positive pressure respiratory support
- infants who have central intravenous lines (e.g., Broviac or peripherally inserted central catheter)
- caregivers who are prisoners
- caregivers who cannot read or speak English
- Conditions
- Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family Choice, Group 2: Skin-to-Skin Care (SSC) Followed by Carrier Care (CC) Followed by Family Choice
- Being tested
- Carrier Care (CC)
- Keywords
- carrier care, skin-to-skin care (ssc), infant carrier, babywearing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carrier Care (CC)Other
Carrier care uses an infant carrier to secure the infant to the caregiver, while SSC does not have a securing device. The caregiver holds the infant with their arms.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Carrier Care (CC) followed by Skin-to-Skin Care (SSC) followed by Family Choice | Other | Carrier Care Receives: Other: Carrier Care (CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Stability
Evaluate the cardiorespiratory stability of the infant during carrier care (CC) or skin-to-skin care (SSC).
Measured: From enrollment to study completion at 15 days.
Secondary outcomes (1)
Thermoregulation
Evaluate the thermal stability of the infant before and after carrier care (CC) and skin-to-skin care (SSC) as measured by an axillary temperature reading of 36.5-37.5°C.
Measured: From enrollment to study completion at 15 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family ChoiceStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Grisham, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07142564
- Sponsor's protocol ID
- STUDY00006871
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still developing the plan
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carrier Care: An Innovative Approach to Support Small Babies in the NICU
- ClinicalTrials.gov ID
- NCT07142564
- Acronym / sponsor ID
- STUDY00006871
- Conditions
- Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family Choice, Group 2: Skin-to-Skin Care (SSC) Followed by Carrier Care (CC) Followed by Family Choice
- Keywords
- carrier care, skin-to-skin care (ssc), infant carrier, babywearing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 26 Aug 2025 (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 significance of skin-to-skin care (SSC) for neonatal infants is well-documented, highlighting its benefits for both the infant and the caregiver. The World Health Organization (WHO) has emphasized the necessity of positioning the infant on the mother after birth in a manner to prevent Sudden Unexpected Postnatal Collapse (SUPC) and accidental drops and falls. SSC is also recommended for 8 hours a day for the first few weeks of life to promote a secure attachment in the infant and bonding with the caregiver.
Despite these established benefits, some families hesitate to engage in skin-to-skin care (SSC) because it is often only done in private settings and requires the caregiver to use their arms to hold the infant in place. Babywearing, or holding the infant to the body of the caregiver using a cloth or infant carrying device, can promote prolonged contact between the caregiver and infant without requiring the caregiver to hold the infant in place with their arms. Babywearing can also be done in more public settings (e.g., grocery store) as the caregiver can remain clothed during babywearing. The purpose of this study is to investigate whether babywearing using a babywearing device, referred to in this study as Carrier Care (CC), is at least as feasible and effective as SSC. This research will evaluate several physiological parameters of the infant, including cardiorespiratory stability, thermoregulation, and oxygen saturation levels. Certified babywearing educators will instruct research participants to ensure proper use of baby carriers and the safety of infants as outlined by the current hospital policy for babywearing.
This study will utilize an amplitude-integrated electroencephalogram (aEEG), a non-invasive, bedside monitoring tool commonly used in neonatal intensive care units (NICUs) to assess brain activity, particularly in premature infants. The aEEG provides a simplified and continuous recording of cortical activity, offering valuable insights into neurological development, including sleep-wake cycling. In this study, the aEEG will be used to evaluate the presence of sleep-wake patterns as a proxy for brain maturation. Data will be collected by placing EEG electrodes on the infant for a total duration of 12 hours: 4 hours prior to the intervention (baseline), 4 hours during the intervention (defined as skin-to-skin contact or carrier care), and 4 hours post-intervention. Recordings will occur on day 3 of the randomized activity to assess potential changes in brain activity associated with the intervention during this critical period of neurodevelopment. Dau 4 or 5 will be used as backup.
Detailed description
A large body of research on skin-to-skin contact (SSC), particularly for preterm infants, provides robust evidence that it benefits both mothers and infants (Koreti \& Muntode Gharde, 2022). Premature infants in the NICU are often separated from their caregivers and placed into an otherwise artificial environment, leading to neurological, sociological, and psychological consequences, along with the impacts of being born prematurely. In addition to positive outcomes, it is notable that SSC is a safe intervention. For example, one review found no negative impact on vital signs or any reports of adverse events before, during, or after SSC (Bisanalli et al., 2023). Overall, SSC shortens hospital stays in the NICU, lowers risks for neonatal infection, increases weight gain, lowers cortisol levels, increases feeding tolerance, and helps with thermoregulation and homeostasis while being safe for the infants and their caregivers participating (Azevedo et al., 2012; Cristóbal Cañadas et al., 2022).
Research on babywearing (close physical contact while clothed or extended arms-free holding) is growing, but a recent scoping review indicates positive biological and behavioral effects for both mothers and infants (Grisham et al., 2023). This research team has previously demonstrated that babywearing effectively increases infant and caregiver comfort among infants diagnosed with Neonatal Abstinence Syndrome (Williams et al., 2020). We recently replicated this finding (Rankin et al., 2024), and also found that babywearing was perceived by nurses as helpful in the care and treatment of these infants (Williams et al., 2021). From the caregiver's perspective, babywearing helps with the tasks of parenting (e.g., calming the infant, putting the infant to sleep), increases bonding time, and is convenient (i.e., provides hands-free to complete other tasks) (Williams, 2020). Our research question is guided by the perspective that if babywearing can closely approximate the benefits of SSC, it would provide a more comfortable and convenient alternative to SSC and potentially extend the benefits by allowing for a greater amount of time spent in close physical proximity.
This project investigates the application of amplitude-integrated electro-encephalography (aEEG) to monitor brain activity and sleep-wake cycling in premature and term neonates in NICU settings. Continuous EEG monitoring for at least 2-3 hours is essential to capture both wakefulness and all stages of sleep. It typically utilizes a compressed display to evaluate slow activity and asynchronies critical in neonatal recordings (Mizrahi \& Kellaway, 2017). The aEEG provides a simplified, bedside tool for long-term monitoring of cerebral function, allowing detection of seizures and assessment of background brain activity patterns (Hellström-Westas et al., 2006) (Shellhaas et al., 2023). aEEG has proven especially useful in neonates with seizures, offering early prediction of neurodevelopmental outcomes based on patterns observed within the first 24 hours after birth (Shellhaas et al., 2023). The early presence of sleep-wake cyclicity on aEEG strongly predicts favorable brain imaging outcomes, while delayed or absent cyclicity is associated with severe abnormalities (Bruns et al., 2017).
Preterm infants show altered sleep patterns compared to term infants, with shorter sleep cycles and increased REM sleep, both of which are essential for brain maturation (Bandyopadhyay et al., 2017). Disrupted or insufficient sleep in NICU infants has been linked to short-term physiological alterations and long-term developmental delays, reinforcing the importance of protecting and promoting sleep quality (Gale et al., 2012; Gertner et al., 2012). aEEG is safe, well-tolerated even by extremely preterm infants, and can be interpreted by neonatal staff due to its simplicity and strong interrater reliability (Hellström-Westas et al., 2006; Toet et al., 2006). This research supports the advancement of non-invasive, accessible neuro-monitoring to guide care and improve neurodevelopmental outcomes in high-risk neonatal populations.
Inclusion Criteria for Infants
Participants for this study will include neonates:
- admitted to the hospital
- who have an estimated length of stay equal to or greater than fifteen (15) days
- weighing greater than or equal to 1800 grams at the time of enrollment
- that are medically stable (free of significant apnea, bradycardia, or desaturations) within the past 48 hours
Inclusion Criteria for Caregivers
Caregivers of infant participants for this study will include:
- caregivers must be 18 years or older,
- those willing to comply with the study protocol, specifically to participate daily in carrier care (CC) and skin-to-skin care (SSC) for fifteen (15) consecutive days.
Exclusion Criteria for Infants and Caregivers
Study participants who will be excluded from this study include:
- infants who require oxygen therapy or positive pressure respiratory support
- infants who have central intravenous lines (e.g., Broviac or peripherally inserted central catheter)
- caregivers who are prisoners
- caregivers who cannot read or speak English
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Carrier Care (CC) followed by Skin-to-Skin Care (SSC) followed by Family Choice | Other | Other: Carrier Care (CC)Carrier Care |
Who may qualify
- Ages
- Up to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- are admitted to the hospital
- who have an estimated length of stay equal to or greater than fifteen (15) days
- weighing greater than or equal to 1800 grams at the time of enrollment
- that are medically stable (free of significant apnea, bradycardia, or desaturations) within the past 48 hours
Key exclusion criteria (4 listed)
- infants who require oxygen therapy or positive pressure respiratory support
- infants who have central intravenous lines (e.g., Broviac or peripherally inserted central catheter)
- caregivers who are prisoners
- caregivers who cannot read or speak 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 |
|---|---|---|
| Carrier Care (CC)Carrier care uses an infant carrier to secure the infant to the caregiver, while SSC does not have a securing device. The caregiver holds the infant with their arms. | Other | Group 1: Carrier Care (CC) followed by Skin-to-Skin Care (SSC) followed by Family Choice |
Primary outcome
Cardiorespiratory Stability
Time frame: From enrollment to study completion at 15 days.
Evaluate the cardiorespiratory stability of the infant during carrier care (CC) or skin-to-skin care (SSC).
1 secondary outcome
Thermoregulation
Time frame: From enrollment to study completion at 15 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided. Still developing the plan
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Carrier Care (CC) in people with Group 1: Carrier Care (CC) Followed by Skin-to-Skin Care (SSC) Followed by Family Choice and Group 2: Skin-to-Skin Care (SSC) Followed by Carrier Care (CC) Followed by Family Choice, run by University of Arizona.
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 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: opening soon, as of the sponsor's last update on 20 Jul 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M Grisham, PhD, DNP, NNP-BC (520-909-3310, lgrisham@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory Stability (time frame: From enrollment to study completion at 15 days.). 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 20 Jul 2026.