A Phase 2/3 interventional study of Skincubator 2 in Preterm and Preterm Birth, sponsored by Itamar Nitzan. Not yet recruiting at 1 site in Australia. Open to participants aged 0 Days to 14 Days. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Itamar Nitzan · Phase 2/3, Interventional, and Treatment
The goal of this clinical trial is to test the feasibility of using the Skincubator, a wearable incubator for skin to skin contact of preterm babies and their parents. It will also learn about the safety of skincubator. The main questions it aims to answer are:
Participants will:
Be offered the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment.
Study design: This is a non-randomized feasibility trial with no control group in which the investigators will offer parents the option to perform Skincubator care - being cared for in SSC inside the Skincubator, which is placed on the mother and/or another caregiver. Skincubator care will be provided from birth if the caring team and the parents feel it is appropriate. The option for Skincubator care will be provided for as long as the parents, surrogates, and staff feel comfortable with a goal of possible achievement of the WHO target of 8 hours per day. Each infant will participate in the study for one week from enrollment (If parents desire, they will be able to continue using the Skincubator beyond 1 week as long as NICU staff feel that it is helpful for the baby).
Implementation phase: Prior to beginning the study, each center will provide care in the Skincubator for five noninvasively ventilated preterm babies. After gaining experience in treating a preterm baby in the Skincubator and performing manikin simulations of Skincubator care for invasively ventilated babies, the NICU team in each center will be able to decide whether to include intubated babies in the trial.
Population: up to 25 preterm neonates in each site, born at GA of 24.0-32.6 with birth weight of \<1.5 kg.
First 3 babies will be of GA of 26-32.6 and on noninvasive respiratory support. Those babies will be considered a learning phase for the team, and may be analyzed separately. After completing the learning phase the study will proceed with 4 groups:
First five babies will be treated in the Skincubator only from NICU admission. After gaining experience with the first 5 babies the team may decide to start Skincubator care in birth suite (ideally on the mother, potentially on the father if the mother prefers or is feeling unwell) or in cesarean section theater (on the father).
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's planned enrollment of 50 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →This is the only study on the registry with Itamar Nitzan as lead sponsor.
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Exclusion Criteria:
This is the only arm. All babies in trial will receive the intervention.
Device: Skincubator 2
The Skincubator is a small incubator designed to attach to the caregiver's torso without any barrier between the parent's chest and the baby. It creates an environment with the advantages of a standard neonatal incubator, while enabling Skin to Skin contact for extended periods from birth. It has multiple access points, to allow for common nursing procedures. It is anchored safely to the parent's body and secures ventilator and IV tubing. It also includes side ports for the parents to insert their hands to touch their baby. The investigators will offer the parents in the intervention group the opportunity to perform Skincubator care for as long as they want to each day during the week after enrolment. The investigators will provide the parents with the aids to accomplish this goal: the Skincubator system with a convenient environment, the option for Skincubator surrogates and, where possible, the option for one of the parents to sleep with the baby safely secured in the Skincubator.
hours of SSC per day
primary neonatal outcome will be hours of SSC per day
Time frame: In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
Parental Stress Scale (PSS) NICU
Parental Stress Scale (PSS) NICU performed by the mother. Minimum and maximum values for PSS NICU are 0 and 72, higher scoring indicates higher parental stress.
Time frame: 4 to 7 days after birth.
Time outside of temperature range 36.5-37.5
Time outside of temperature range 36.5-37.5 measured axillary
Time frame: In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
time in environmental humidity of less than 60%
time in environmental humidity of less than 60% measured by hygrometer and incubator hygrometer
Time frame: In the first week from study commencement (study commencement will be defined as birth or receiving consent, whichever occurs later).
Plan to share: Undecided — The investigators will need to discuss with local IRBs
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Sep 2026, 24 months later.
Of 17 phase 2/3 interventional studies under Premature Birth, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's planned 24 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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