Preterm Infant DevelopmentNCT07306000
Pilot Study: Effects of CCP Intervention on NICU Environment and Preterm Infants Development
A study testing Close Collaboration with Parents training in people with Preterm Infant Development and Preterm Infant Health, run by Turku University Hospital at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 7 days
- Conditions the study is for
- Preterm Infant Development, Preterm Infant Health
- What is being tested?
- Close Collaboration with Parents training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 22 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- preterm infants born below 32 weeks of gestation and/or weighing < 1500 g who receive long-term follow-up at each study site.
Who cannot join
- 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 locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Japan2 sites, 2 recruiting
- Not yet recruiting
Kyoto University Hospital
Kyoto
Seiichi Tomotaki, +81-90-9828-5252, stomotaki@kuhp.kyoto-u.ac.jp
- Not yet recruiting
Nagano Children's Hospital
Matsumoto, Nagano
Ryo Itoshima, 82-90-8122-9033, itoshima.ryo@gmail.com
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital NICU
Seoul, 02841
Juyoung Lee, Professor, 82-2-920-6603, juyounglee@korea.ac.kr
About this study
Official title: Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study
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 Development, Preterm Infant Health
- Being tested
- Close Collaboration with Parents training
- Keywords
- close collaboration with parents, family-centered care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Close Collaboration with Parents trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Close Collaboration with Parents training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
The hospitalization duration and the postmenstrual age (PMA) at NICU discharge will be collected from the medical records.
Measured: at the day of NICU discharge (up to 40 weeks of postmenstrual age)
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.
Measured: at the term age, between 37+0 and 41+6 weeks of postmenstrual age
Parent-infant interaction: eye movement and behavior tracking
The measurements will be done during a structured test situation. The mother or father and the child are positioned face-to-face at a table and engaged with a standardized set of toys for 10 minutes. The parent will wear glasses with an eye tracker and a camera. The child will not wear such devices due to the high rates of data attrition for child-held devices. Infant face-looking will be analyzed using a deep neural network based on the video data recorded by the parent's glasses. Parent's face-looking behavior will also be extracted from the eye tracking and video data recorded by the parent's glasses. Parent reactions to child face-looking (facial and vocal) will be obtained from a separate video and audio recording, using automatic tools.
Measured: at 6 months of corrected age, for 10 minutes
Cry diary
The duration of the infants crying at home will be recorded using the Cry Diary. The parents record baby's state to 6 categories (sleeping, awake \& happy, awake \& fussy, awake \& crying, feeding, not sure) and parents' action to 3 categories (holding the baby, transport, baby care) with 5-minute accuracy using the Cry Diary for 3 consecutive days, shortly before the 6 months corrected age follow-up visit.
Measured: at 6 months of corrected age, for 3 days
Infant Behavior Questionnaire-Revised (IBQ-R)
The IBQ-R has 191 items in which parents rate their infant's behavior over the past one to two weeks on a 7-point Likert scale (1 = never, 7 = always) based on the frequency of the observed behavior. If a behavior was not observed, parents mark it as "not applicable". The items form three broad temperament dimensions with subscales: Surgency/Extraversion (Approach, Vocal Reactivity, High Intensity Pleasure, Smiling and Laughter, Activity Level), Negative Affectivity (Perceptual Sensitivity, Sadness, Distress to Limitations, Fear, Falling Reactivity), Orienting/Regulatory Capacity (Low Intensity Pleasure, Cuddliness, Duration of Orienting, Soothability). The IBQ-R has shown predictive validity for later child temperament and behavioral outcomes.
Measured: at 6 months of corrected age
Early Childhood Behavior Questionnaire (ECBQ)
The ECBQ consists of 201 items and has the same 7-point scale as the IBQ-R. It measures three broad dimensions of temperament, each with multiple subscales: Surgency/Extraversion (Activity Level, High-Intensity Pleasure, Sociability, Impulsivity, Approach, Shyness), Negative Affectivity (Fear, Frustration, Discomfort, Sadness, Soothability), Effortful Control (Attention Focusing, Cuddliness, Inhibitory Control, Low-Intensity Pleasure, Perceptual Sensitivity. The ECBQ has shown predictive validity for children's later emotional and behavioral regulation.
Measured: at 18 months of corrected age
Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
Bayley scale scores for each development areas (cognitive, language, motor) score range : 0-200 above average (1 to -2 standard deviation, score 116-130) average (1 to -1 standard deviation, score 85-115) below average (1 to -2 standard deviation, score 84-70) well below average (<-2 standard deviation, scores < 70).
Measured: at 18 months of corrected age and 3 years of age
Infant Toddler Social Emotional Assessment (ITSEA)
The ITSEA is a screening method for infants between 12 and 36 months of age to predict their future social and emotional problems. It has 170 items, each rated from 0 (not true/rarely) to 2 (very true/often).
Measured: at 18 months of corrected age and 3 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start22 Dec 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Liisa Lehtonen, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306000
- Sponsor's protocol ID
- PilotStudy/2025
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision has not yet been made regarding whether to share individual participant data or not. Because individual participant data contains a large amount of metric data and personal developmental outcomes, the researchers will discuss this matter further before making a decision.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Close Collaboration With Parents Intervention on NICU Care Environments and Long-term Development of Preterm Infants: a Pilot Study
- ClinicalTrials.gov ID
- NCT07306000
- Acronym / sponsor ID
- PilotStudy/2025
- Conditions
- Preterm Infant Development, Preterm Infant Health
- Keywords
- close collaboration with parents, family-centered care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Close Collaboration with Parents trainingAfter 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. |
Who may qualify
- Ages
- 1 hour to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- preterm infants born below 32 weeks of gestation and/or weighing < 1500 g who receive long-term follow-up at each study site.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Close Collaboration with Parents trainingThe 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. | Behavioural | Post-intervention |
Primary outcome
Auditory environment: parent and adult speech
Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
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.
Auditory environment: sound level and its variation
Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
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.
Sensitive care: sleep quality and quantity
Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
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.
Parents' presence and parent-infant skin-to-skin contact
Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
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.
Type of enteral feeding
Time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)
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.
Body weight
Time frame: 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
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.
10 secondary outcomes
Breastfeeding
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)
Parents' parenting self-efficacy
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 age
Length of stay and PMA at discharge
Time frame: at the day of NICU discharge (up to 40 weeks of postmenstrual age)
Brain MRI
Time frame: at the term age, between 37+0 and 41+6 weeks of postmenstrual age
Parent-infant interaction: eye movement and behavior tracking
Time frame: at 6 months of corrected age, for 10 minutes
Cry diary
Time frame: at 6 months of corrected age, for 3 days
Infant Behavior Questionnaire-Revised (IBQ-R)
Time frame: at 6 months of corrected age
Early Childhood Behavior Questionnaire (ECBQ)
Time frame: at 18 months of corrected age
Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
Time frame: at 18 months of corrected age and 3 years of age
Infant Toddler Social Emotional Assessment (ITSEA)
Time frame: at 18 months of corrected age and 3 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided. A decision has not yet been made regarding whether to share individual participant data or not. Because individual participant data contains a large amount of metric data and personal developmental outcomes, the researchers will discuss this matter further before making a decision.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Close Collaboration with Parents training in people with Preterm Infant Development and Preterm Infant Health, run by Turku University Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sari Ahlqvist-Björkroth (358-40-511-9600, sarahl@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory environment: parent and adult speech (time frame: Once a week, for 24 hours (every 7 days, up to 40 weeks of postmenstrual age)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.