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

19. august 2026 opdateret af: Jaclyn Ruggiero, The University of Texas Health Science Center, Houston
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Skincubator-supported SSC
Enhed: 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
Aktiv komparator: Traditional SSC (t-SSC)
Andet: t-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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average daily duration of SSC
Tidsramme: First 7 days following randomization
this will be recorded as mean hours/day
First 7 days following randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety as assessed by the incidence of predefined adverse events(AEs)
Tidsramme: 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
From randomization through NICU discharge (upto 100 days from randomization)
Safety as assessed by the number of infants that experience adverse events
Tidsramme: From randomization through NICU discharge (upto 100 days from randomization)
From randomization through NICU discharge (upto 100 days from randomization)
Safety as assessed by the propotion of infants that experience adverse events
Tidsramme: From randomization through NICU discharge (upto 100 days from randomization)
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
Tidsramme: 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.
end of intervention (7 days after randomization)
Acceptability as assessed by the Acceptability of Intervention Measure (AIM) among parents and clinical staff.
Tidsramme: 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.
end of intervention (7 days after randomization)
Thermal Stability as assessed by the percentage of SSC session time
Tidsramme: During SSC sessions in first 7 days post randomization
During SSC sessions in first 7 days post randomization
Change in parental stress as assessed by the Parental Stressor Scale:NICU (PSS:NICU) score
Tidsramme: 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.
Baseline, days 5-7 post-randomization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center, Houston

Efterforskere

  • Ledende efterforsker: Jaclyn Ruggiero, MD, The University of Texas Health Science Center, Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. juli 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

18. juli 2026

Først indsendt, der opfyldte QC-kriterier

18. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • HSC-MS-25-1097

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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