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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

Lisa M Grisham, PhD, DNP, NNP-BC contact

520-909-3310

lgrisham@arizona.edu

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
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 groups in NCT07142564
Study groupRoleWhat they receive
Group 1: Carrier Care (CC) followed by Skin-to-Skin Care (SSC) followed by Family ChoiceOtherCarrier Care
Receives: Other: Carrier Care (CC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted26 Aug 2025
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

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)
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

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.

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