Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-7
SponsorTurku University Hospital
About this trial
Close Collaboration with Parents intervention is an evidence-based educational intervention for the entire multi-professional staff of neonatal intensive care units (NICUs). The goal of the intervention is to strengthen partnership between staff and parents, enhance parental participation in infant care. There are no studies yet about the effects of the Close Collaboration with Parents intervention on the long-term neurodevelopment and socio-emotional development of very preterm infants and their interaction with their parents. Accordingly, a multicenter cluster randomized controlled trial is planned. Prior to initiating this large-scale study, it is essential to validate the measurement instruments. Therefore, a pilot study will be conducted to assess their feasibility and to determine the appropriate sample size.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
preterm infants born below 32 weeks of gestation and/or weighing < 1500 g who receive long-term follow-up at each study site.
Disqualifiers
the infant has any major anomalies
the infants are triplets or higher order
the infant's condition is critical and the survival is uncertain
the parents cannot understand the informed consent form in Korean or in Japanese
Trial design
Design model
Crossover
Treatments tested in this trial
Close Collaboration with Parents training
BehavioralThe Close Collaboration with Parents is an educational intervention for neonatal health care staff. The "train the trainer" model is used in the implementation so that the training team trains local mentors in each NICU, who then mentor the other neonatal health care staff. Local mentors are chosen from the neonatal health care team (nurses, doctors, or psychologists) working in the NICU. The learning process of neonatal health care teams includes completing the e-learning module and bedside practices combined with reflection on the practice experience with a local mentor. The final goal is to improve the family-centered care culture of the NICU by developing the skills of the neonatal health care team to communicate and collaborate with parents and to provide support for parenting.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Pre-interventionNo intervention 0 interventions
Group B: Post-interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Auditory environment: parent and adult speech
The quantity of adult speech is recorded and analyzed. The quantity of adult speech includes the duration (minutes per hour), number of words (per hour), syllables (per hour), and phonemes (per hour). The recording is done with a commercial recording device. The microphone is placed in the incubator or infant cot. The data analyses are performed using ALICE, an open-source tool to count words, syllables, and phonemes.
Time frame
Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)2
Auditory environment: sound level and its variation
The sound level includes sound pressure (dB) and its variation. The main focus of this measurement is to detect a sudden change in the sound pressure caused by alarms and other activities which are a common source of stress in a NICU environment. The recording is done with a sound level detector, a different device from that for speech recording. The microphone is placed in the incubator or infant cot. The data analyses are performed using a one-minute resolution of the recording regarding the average, maximum and minimum and 5 and 95 percentiles of the sound level.
Time frame
Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)3
Sensitive care: sleep quality and quantity
The artificial intelligence-based algorithm tool to analyze infant behavior with a camera captured image will be used to classify infant state into six categories: Non-REM (rapid eye movement) sleep, REM (rapid eye movement) sleep, drowsy, quiet awake, active awake, and crying. In addition, caretaking and procedures will be recorded and scored. The diary data is used to get information of the times the infants is not under the camera image like during skin-to-skin contact. The camera is custom-designed with the connection to a local computer. The night-vision camera works well also in a dimmed light environment. The module can be used for both infants in an incubator and in an open bed.
Time frame
Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)4
Parents' presence and parent-infant skin-to-skin contact
Parents' presence is defined as their presence beside their infant or at least in the same room with the infant. Parent-infant skin-to-skin contact is defined as the infant being held by the parent on the bare chest, with only a diaper and a cap if necessary. The duration of parents' presence and parent-infant skin-to-skin contact will be recorded using a modified Parent-Infant Closeness Diary. Parents or staff indicate the specific items by drawing a line. The caretaking includes hands-on care and holding, breastfeeding and bottle feeding of the infant. The start and the end times should be put in 5-minute increments.
Time frame
Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)Secondary outcomes
1
Breastfeeding
The frequency (times per day) and proportion (% of total feeding number per day) of breastfeeding will be recorded between 36+0 and 36+6 weeks of postmenstrual age and between 7 and 1 day before the day of NICU discharge. Then the average frequency and proportion of breastfeeding at 36 weeks of postmenstrual age and at NICU discharge will be calculated.
Time frame
between 36+0 and 36+6 weeks of postmenstrual age (7 days), and between 7 and 1 day before the day of NICU discharge (7 days)2
Parents' parenting self-efficacy
The questionnaire consists of 26 questions about the parenting self-efficacy. Each question is rated by parents using a Likert scale from 1 (fully disagree) to 6 (fully agree).
Time frame
at 36 weeks of postmenstrual age, at the day of NICU discharge (up to 40 weeks of postmenstrual age), and 1 month of corrected age3
Length of stay and PMA at discharge
The hospitalization duration and the postmenstrual age (PMA) at NICU discharge will be collected from the medical records.
Time frame
at the day of NICU discharge (up to 40 weeks of postmenstrual age)4
Brain MRI
The brain MRI will be taken at the term age, between 37+0 and 41+6 weeks of postmenstrual age or shortly before the NICU discharge. The brain MRI image will be evaluated using a standardized scoring system, that consists of six items for white matter injury and seven for gray matter injury. The total score is 17 for white matter and 22 for gray matter and cerebellum. A higher score indicates better brain development. The severity of the injury is defined using the total score for white and gray matter, respectively.
Time frame
at the term age, between 37+0 and 41+6 weeks of postmenstrual ageSponsors and contacts
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Source ClinicalTrials.gov