Skin to Skin Care for Preterm Infants
Conditions
Keywords
skin to skin care, pre term infant, skincubator
Brief summary
The purpose of this study is to assess the impact of the Skincubator on average daily duration of Skin-to-skin Care (SSC), to assess the safety of Skincubator-supported SSC during NICU hospitalization, to evaluate feasibility and acceptability of the Skincubator among parents and clinical staff using the Acceptability of Intervention Measure (AIM) implementation framework to assess thermal stability during Skincubator-supported SSC and to assess changes in parental stress associated with Skincubator use during NICU hospitalization.
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Days
Healthy volunteers
No
Inclusion criteria
-Extremely preterm (EP) and preterm (PT) infants born between 24 0/7 and 30 6/7 weeks' gestational age (GA)
Exclusion criteria
* Birth weight \> 2kg. * Hemodynamic instability, defined as new or escalating inotropic support within 12 hours prior to randomization * Chest tube in place at time of enrollment. * Oxygenation failure, defined as persistent preductal oxygen saturation \< 85% despite 100% fraction of inspired oxygen (FiO2). * Recurrent apnea, requiring bag-mask ventilation more than twice within the 12 hours prior to randomization * Known or suspected congenital anomalies or genetic conditions, including Trisomy 13, 18, 21 or cystic fibrosis Multiple gestation, including twins or higher-order multiples * Determination by the attending neonatologist that participation is not safe for a given infant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average daily duration of SSC | First 7 days following randomization | this will be recorded as mean hours/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thermal Stability as assessed by the percentage of SSC session time | During SSC sessions in first 7 days post randomization | — |
| Safety as assessed by the incidence of predefined adverse events(AEs) | From randomization through NICU discharge (upto 100 days from randomization) | 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 |
| Safety as assessed by the number of infants that experience adverse events | From randomization through NICU discharge (upto 100 days from randomization) | — |
| Safety as assessed by the propotion of infants that experience adverse events | From randomization through NICU discharge (upto 100 days from randomization) | — |
| Feasibility of Skincubator-supported SSC as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff | end of intervention (7 days after randomization) | 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. |
| Change in parental stress as assessed by the Parental Stressor Scale:NICU (PSS:NICU) score | Baseline, days 5-7 post-randomization | 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. |
| Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff. | end of intervention (7 days after randomization) | 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. |
Countries
United States
Contacts
CONTACTJaclyn E Ruggiero, MD
CONTACTMatthew Rysavy
PRINCIPAL_INVESTIGATORJaclyn Ruggiero, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed