Skin-to-skin Care Using the Skincubator: Feasibility and Safety Trial

Keywords

• skin to skin care
• pre term infant
• skincubator

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Study arms

• Experimental
  Skincubator-supported SSC

  Device: Skincubator-supported SSC

• Active comparator
  Traditional SSC (t-SSC)

  Other: t-SSC

Interventions

• DeviceSkincubator-supported SSC

  Participants will receive SSC using the Skincubator, a novel wearable neonatal device designed to support a warm, humidified environment during SSC sessions. The device includes a retractable transfer pad, a secure line management nest, and a transparent top cover with multiple access points for routine care

• Othert-SSC

  Infants in the control group will receive routine care, including t-SSC per NICU protocol without the use of a supportive device. Parents will be encouraged to engage in SSC as frequently and for as long as possible. To ensure equitable support, control group families will receive the same educational materials, planning tools, and comfort measures as those in the intervention group. SSC will be facilitated using typical swaddling techniques without the use of the Skincubator.

Primary outcomes

1. Average daily duration of SSC

   this will be recorded as mean hours/day

   Time frame: First 7 days following randomization

Secondary outcomes

1. Safety as assessed by the incidence of predefined adverse events(AEs)

   AEs include * Respiratory tube or vascular access dislodgment * Skin breakdown, bruising, or compromise of skin integrity * Falls during SSC or during parent sleep * Moderate hypothermia or hyperthermia (as defined below) lasting more than 30 minutes * Apnea requiring bag-mask ventilation and escalation to cardiopulmonary resuscitation * Cardiorespiratory instability requiring escalation of support (e.g., new or increased mechanical ventilation) * Hemodynamic deterioration requiring volume resuscitation or inotropes * Withholding of feeds due to suspected Necrotizing Enterocolitis (NEC) * Severe complications such as Intraventricular Hemorrhage (IVH), NEC, or death

   Time frame: From randomization through NICU discharge (upto 100 days from randomization)

2. Safety as assessed by the number of infants that experience adverse events

   Time frame: From randomization through NICU discharge (upto 100 days from randomization)

3. Safety as assessed by the propotion of infants that experience adverse events

   Time frame: From randomization through NICU discharge (upto 100 days from randomization)

4. Feasibility of Skincubator-supported SSC as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff

   This is a 4 item questionnaire and each is scored from 1(completely disagree)-5 (completely agree) for a total score range of 4-20. Higher scores indicate greater acceptability of the intervention.

   Time frame: end of intervention (7 days after randomization)

5. Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff.

   This is a 4 item questionnaire and each is scored from 1(completely disagree)-5 (completely agree) for a total score range of 4-20. Higher scores indicate greater acceptability of the intervention.

   Time frame: end of intervention (7 days after randomization)

6. Thermal Stability as assessed by the percentage of SSC session time

   Time frame: During SSC sessions in first 7 days post randomization

7. Change in parental stress as assessed by the Parental Stressor Scale:NICU (PSS:NICU) score

   this is a 26 item questionnaire and each is scored on a 5-point likert scale from 1-5); higher scores indicate greater parental stress.

   Time frame: Baseline, days 5-7 post-randomization

Individual participant data

Plan to share: No