Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development

NCT07306000 | Recruiting

• 1 other identifier: PilotStudy/2025
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Preterm Infant Health; Preterm Infant Development

Keywords

close collaboration with parents; family-centered care

Outcome Measures

Primary Outcomes (6)

• 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.

  Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)

• 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.

  Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)

• 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.

  Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)

• 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.

  Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)

• Type of enteral feeding

  The amount of enteral feeding divided into 4 categories, fresh breast milk, refrigerated/frozen breast milk, donated breast milk, and formula milk will be collected per day. Both the absolute amount of milk and its proportion of the total enteral nutrition will be calculated. We hypothesize that the infants will receive more fresh maternal milk after the intervention.

  Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)

• Body weight

  The body weight of the participated infant, and its percentile/Z-score based on the standardized growth curve (Fenton 2025 and National growth curve) will be collected.

  every 7 days, from enrollment to the NICU discharge (up to 40 weeks of postmenstrual age), 1 month of corrected age, 6 months of corrected age, 18 months of corrected age, and 36 months

Secondary Outcomes (10)

• Breastfeeding

  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)

• Parents' parenting self-efficacy

  at 36 weeks of postmenstrual age, at the day of NICU discharge (up to 40 weeks of postmenstrual age), and 1 month of corrected age

• Length of stay and PMA at discharge

  at the day of NICU discharge (up to 40 weeks of postmenstrual age)

• Brain MRI

  at the term age, between 37+0 and 41+6 weeks of postmenstrual age

• Parent-infant interaction: eye movement and behavior tracking

  at 6 months of corrected age, for 10 minutes

Study Arms (2)

Pre-intervention

NO INTERVENTION

Prior to the implementation of the Close Collaboration with Parents (CCP) training program, staff provide routine care according to standard NICU practices.

Post-intervention

EXPERIMENTAL

After the implementation of the CCP training program, all NICU staff participate in the intervention, applying the learned practices to include parents in the care of their infants in the NICU.

Behavioral: Close Collaboration with Parents training

Interventions

Close Collaboration with Parents training BEHAVIORAL

The 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.

Post-intervention

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm infants born below 32 weeks of gestation and/or weighing \< 1500 g who receive long-term follow-up at each study site.

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (3)

Nagano Children's Hospital

Matsumoto, Nagano, Japan

NOT YET RECRUITING

Kyoto University Hospital

Kyoto, Japan

NOT YET RECRUITING

Korea University Anam Hospital NICU

Seoul, 02841, South Korea

RECRUITING

Central Study Contacts

Sari Ahlqvist-Björkroth

CONTACT

358-40-511-9600; sarahl@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1. Unidirectional crossover design within one center: self-controlled comparison (pre- vs. post-intervention) 2. Stepped-wedged cluster study across multi-centers: parallel comparison (NICU A post-intervention vs. NICU B/C pre-intervention)

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 26, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

JP (2); KR (1)