Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04727125 |
| Other study ID # |
2019-2539 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 17, 2019 |
| Est. completion date |
January 1, 2022 |
Study information
| Verified date |
March 2022 |
| Source |
Ann & Robert H Lurie Children's Hospital of Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The main hypothesis of this study is that Kangaroo Father Care (KFC) will positively impact
acute physiologic and long-term behavioral outcomes in infants, fathers, and families.
Description:
Screening:
Participants will be recruited from the NICU at Prentice Women's Hospital. A member of the
study team will screen all NICU patients for inclusion and exclusion criteria by reviewing
electronic medical records. A screening and enrollment log will be kept to track families who
have been approached and agreed or declined to participate in the study. The screening and
enrollment log will be kept on a secure REDCap server housed by Northwestern University. Only
the study team will have access to this log.
Kangaroo Care (KC) Intervention:
After enrollment, families will be scheduled to participate in two sessions of KC over two
sequential days. The goal will be to schedule the KC sessions for the same time of day (i.e.
morning, afternoon, or evening). However, if this is not possible given the parents', the
sessions will be scheduled for any time of day that participating parents are able to visit
their infant in the NICU. Each session will include two hours of continuous KC, with one day
focused on Kangaroo Mother Care (KMC) and the other on Kangaroo Father Care (KFC), in a
randomized order. These sessions will include continuous skin-to-skin holding of the infant
by the parent, per standard of care protocol.
Physiologic Recording:
1) Infant: Prior to the first scheduled KC session, two wearable, wireless biosensors will be
placed on the infant to continuously capture physiology measures including electrocardiogram
(ECG), heart rate (HR), oxygen saturation (SpO2), body temperature, respiratory rate,
movement, systolic blood pressure (BP-S), and others for the duration of the study. One
device will be placed on the infant's chest or back. A second device will be placed
peripherally, on the infant's leg, foot, arm, or hand. The devices are encapsulated in a
medical-grade silicone and will be adhered to the infant's skin using a medical-grade
adhesive, similar to the adhesives standardly used in the NICU. The biosensors will be left
in place for up to 48 hours, but will be checked by study staff at least once every 24 hours
to ensure skin integrity and signal quality. The adhesives will be changed between uses. 2)
Parent: The same type of wearable, wireless biosensor will also be used to record 4 hours of
continuous physiology including ECG, HR, temperature, movement, SpO2, and others in the
infant's parents. The biosensor will be placed on the parent's chest 1 hour before the start
of a scheduled KC session and worn for 1 hour preceding the scheduled KC session, during the
2-hour KC session, and for 1 hour after the completion of the KC session. The biosensor will
be worn by the parents for approximately 4 hours in total.
Skin Monitoring:
Before and after the wearable biosensors are placed on the infant, the infant's skin
integrity will be evaluated using the age-appropriate, NICU standard of care protocol for
monitoring skin integrity. Study staff will take photographs of the skin at the site of
biosensor placement before the biosensors are placed and after the biosensors are removed.
Skin changes occurring while the biosensor is adhered to the infant's skin will be documented
photographically. No faces will be photographed. The study team will consult the bedside care
team within 1 hour for any ≥2 changes in skin integrity (based on the age-appropriate skin
integrity scale score).
Video Monitoring:
In some patients, video monitoring of patient position and movement will be utilized during
the study. This is an optional, additional part of the study in which families can choose to
participate or not participate. For participating patients/families, a video camera will be
mounted in the patient room for the duration of the KC sessions.
Saliva Sample Collection:
Saliva will be collected from enrolled infants and parents non-invasively to evaluate the
effects of KFC on established biomarkers of stress (cortisol and testosterone) and
father-infant bonding (oxytocin). Before, during, and after each KC session, saliva will be
collected from the participating parent, and their infant. A trained member of the study team
will collect saliva from infants using oral swabs made from an inert polymer and
appropriately sized for an infant mouth (approximately 5 mm). Oral swabs will be taken from
the infant immediately prior to beginning a KC session (T1), 30 minutes into the KC session
(T2), and 30minutespost-session (T3). Parents will self-collect saliva samples at the time
points outlined above, using an adult-sized oral swab. At T2, the trained study team member
will be able to help the parent collect the saliva sample, if necessary, while the parent
continues to hold their infant. This approach to salivary sample collection and biomarker
analysis is similar to that established by previous studies of kangaroo care and takes into
consideration the30-minute delay before cortisol reactivity in saliva.
Saliva Questionnaires:
When saliva is collected from parents at time points T1, T2, and T3, parents will also be
asked to complete a brief saliva questionnaire. These questionnaires will take approximately
five minutes each to complete and will be completed on paper or directly in REDCap, depending
upon the participant's preferences. At T2, a study team member will be able to help the
parent complete the survey, if necessary, while the parent continues to hold their infant.
Data provided on surveys completed on paper will be transferred to secure REDCap forms by
study staff and destroyed within 24 hours. All questionnaire data will be stored long term on
the secure REDCap server housed by Northwestern University.
Psychosocial Questionnaires:
This study will employ psychosocial measures to capture the short- and long-term impacts of
KFC. Specifically, validated measures of parenting confidence, relationship quality, infant
bonding, and father involvement will be assessed via a set of paper or REDCap surveys
administered in the NICU (short term) at baseline and the day before discharge (T-1) , and at
home (long term) at 2 weeks (T+14) and 4 weeks (T+30) after discharge. Each of these sets of
surveys will take approximately 30 minutes to complete. At baseline, each parent will
complete the Revised Dyadic Adjustment Scale (RDAS) and the Postpartum Bonding Questionnaire
(PBQ). At T-1, each parent will complete the RDAS , the PBQ, and the Parenting Sense of
Competence Scale (PSOC). These questionnaires will be completed on paper or directly in
REDCap, depending upon the participant's preferences. Data provided on surveys completed on
paper will be transferred to secure REDCap forms by study staff and destroyed within 24
hours. At T+14 and T+30, each parent will complete the RDAS, the PBQ, the PSOC, and a Father
Involvement Questionnaire. These questionnaires will be completed directly in REDCap only.
Each parent will receive an email containing a link to their set of questionnaires at both
post-discharge time points. All questionnaire data will be stored long term on the secure
REDCap server housed by Northwestern University.
Wearable Sensor Data Collection:
The wearable sensor that will be used in this study can stream data continuously using near
field communication (NFC) or Bluetooth technology. An encrypted laptop, iPad, or similar
device will be left in the patient room and used to capture the continuous data stream from
the wearable sensor. Additionally, wearable biosensors can include onboard memory, and
physiologic streams may be recorded to this onboard memory until transfer to an encrypted
laptop for analysis.
Standard of Care Data Collection:
In all patients in rooms where data from standard of care monitoring is recorded on the
BedMaster system, this data will be used for comparison to data captured using the wearable
sensors. In participants in rooms where this system is not available, the MediCollector
system will be used to capture background data during the approximately 48-hour study.
