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

The University of Texas Health Science Center, Houston60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Skin to Skin Care for Preterm Infants

Interventions

Skincubator-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

t-SSCOTHER

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.

Eligibility

Sex: ALLMax age: 6 Days

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Average daily duration of SSC

this will be recorded as mean hours/day

Time frame: First 7 days following randomization

Secondary Outcomes

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)

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

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

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

Time frame: 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

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)

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)

Thermal Stability as assessed by the percentage of SSC session time

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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts