Prematurity of FetusPAP-UKNCT07747870
Daily Skin-to-Skin Contact Duration in Preterm and Low Birth Weight Infants Admitted to a Kangaroo Care Unit
An observational study of Prematurity of Fetus and Low Birth Weight Baby, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial summary
Kangaroo Mother Care promotes prolonged skin-to-skin contact between newborns and their parents. Although this practice is routinely encouraged in Kangaroo Care Units, the daily duration of skin-to-skin contact varies substantially between families. Read more about this study
- Who is it for?
- Ages 1 minute to 72 hours
- Conditions the study is for
- Prematurity of Fetus, Low Birth Weight Baby
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2021to 22 Mar 2025
- How long will I take part?
- 11 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 minute to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: Preterm and/or low birth weight newborns admitted to the Kangaroo Unit of Valenciennes Hospital within the first 72 hours of life.
Who may be able to join
- Preterm newborn with a gestational age between 33 weeks 0 days and 34 weeks 6 days and/or a birth weight of 1500g and 2000 g
- admitted to the Kangaroo Unit within the first 72 hours after birth
Who cannot join
- Mother-infant separation lasting more than 72 hours after birth
- Triplet or higher-order multiple pregnancy
- Refusal of participation by one or both parents
- Cognitive impairment preventing provision of study information to a parent and/or collection of study data
- Inability to communicate with the parents (e.g. language barrier)
- Mother deprived of liberty
- No health insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Daily Skin-to-Skin Contact Duration in the Valenciennes Kangaroo Care Unit
Kangaroo Mother Care promotes prolonged skin-to-skin contact between newborns and their parents. Although this practice is routinely encouraged in Kangaroo Care Units, the daily duration of skin-to-skin contact varies substantially between families.
This prospective observational study aims to estimate the average daily duration of skin-to-skin contact among newborns admitted to the Kangaroo Unit at Valenciennes Hospital and to identify maternal, neonatal, and organizational factors associated with this practice.
Read more
This non-interventional study does not modify routine clinical care. Data are collected from routinely available medical records, a brief parental questionnaire completed at enrollment, and the daily recording of skin-to-skin contact performed throughout hospitalization.
The study will provide a description of skin-to-skin practice in a specialized Kangaroo Unit and may help inform future strategies to support the implementation of Kangaroo Mother Care.
Read the detailed description
Background
Kangaroo Mother Care (KMC) combines prolonged skin-to-skin contact between the newborn and a parent with breastfeeding support whenever possible. Evidence from randomized trials and systematic reviews has demonstrated that KMC improves physiological stability, breastfeeding, sleep organization, pain management, neurodevelopment, parent-infant bonding, and parental well-being in preterm infants.
Although KMC is widely recommended for clinically stable preterm infants, substantial variation exists in its implementation across neonatal units. Daily skin-to-skin duration differs considerably between families, even in dedicated Kangaroo Units where continuous parent-infant proximity is encouraged. The reasons for this variability remain incompletely understood.
The Kangaroo Unit at Valenciennes Hospital has routinely implemented Kangaroo Mother Care since 2005. A previous observational evaluation demonstrated that prolonged daily skin-to-skin contact could be achieved safely within this setting. However, important differences in practice between families were observed.
Rationale
Characterizing the actual duration of skin-to-skin contact and identifying factors associated with longer or shorter daily practice may improve understanding of how Kangaroo Mother Care is implemented in routine clinical care. Identifying modifiable determinants may help optimize support for families and improve organization of care within Kangaroo Units.
Study Description
This is a prospective, single-center, observational study conducted in the Kangaroo Unit of the Neonatal Department at Valenciennes Hospital.
Eligible newborns admitted to the Kangaroo Unit will receive standard clinical care according to routine practice. No study-specific intervention, treatment, or additional examination is performed.
Clinical and demographic information is obtained from routinely collected medical records. Additional information regarding parental characteristics and information received about Kangaroo Mother Care is collected using a brief questionnaire administered at enrollment. The duration of skin-to-skin contact is recorded prospectively throughout hospitalization using the routine daily documentation completed by healthcare professionals.
The primary objective is to estimate the average daily duration of skin-to-skin contact during hospitalization in the Kangaroo Unit. Secondary analyses will explore maternal, neonatal, and organizational factors that may be associated with variations in daily skin-to-skin duration.
Significance
This study will provide contemporary data describing the implementation of Kangaroo Mother Care in a specialized Kangaroo Unit. Better understanding of the factors associated with skin-to-skin practice may support future quality improvement initiatives aimed at facilitating prolonged parent-infant skin-to-skin contact during neonatal hospitalization.
- Conditions
- Prematurity of Fetus, Low Birth Weight Baby
- Keywords
- Kangaroo Mother Care, Skin-to-skin Contact, Kangaroo Care, Neonatal Care, Family-Centered Care, Parent-Infant Bonding, Neonatology, Late Preterm Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Unit Cohort | Eligible infants admitted to the Kangaroo Unit who received routine Kangaroo Mother Care according to standard clinical practice during hospitalization. The study was observational and did not modify patient management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily duration of skin-to-skin contact
Average duration of skin-to-skin contact per day (hours/day) during hospitalization in the Kangaroo Unit, excluding the admission and discharge days. Daily duration is routinely recorded by healthcare professionals.
Measured: Up to 25 days (until discharge from the Kangaroo Unit)
Secondary outcomes (1)
Association between parental, neonatal, socioeconomic, obstetric, postnatal and organizational characteristics and average daily duration of skin-to-skin contact
The association between parental, neonatal, socioeconomic, obstetric, postnatal and organizational characteristics and the average daily duration of skin-to-skin contact (hours/day) will be assessed using a linear mixed-effects model.
Measured: Up to 25 days (until discharge from the Kangaroo Unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start10 Jun 2021
- Primary completion13 Mar 2025
- Study completion22 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity of FetusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
- Target duration
- 11 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sabine Réthoré, Principal investigator, Centre Hospitalier de Valenciennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747870
- Sponsor's protocol ID
- RNI_2021_01
- Acronym
- PAP-UK
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Daily Skin-to-Skin Contact Duration in the Valenciennes Kangaroo Care Unit
- ClinicalTrials.gov ID
- NCT07747870
- Acronym / sponsor ID
- PAP-UK / RNI_2021_01
- Conditions
- Prematurity of Fetus, Low Birth Weight Baby
- Keywords
- Kangaroo Mother Care, Skin-to-skin Contact, Kangaroo Care, Neonatal Care, Family-Centered Care, Parent-Infant Bonding, Neonatology, Late Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 22 Mar 2025 (actual)
- First posted
- 5 Aug 2026 (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.
Kangaroo Mother Care promotes prolonged skin-to-skin contact between newborns and their parents. Although this practice is routinely encouraged in Kangaroo Care Units, the daily duration of skin-to-skin contact varies substantially between families.
This prospective observational study aims to estimate the average daily duration of skin-to-skin contact among newborns admitted to the Kangaroo Unit at Valenciennes Hospital and to identify maternal, neonatal, and organizational factors associated with this practice.
This non-interventional study does not modify routine clinical care. Data are collected from routinely available medical records, a brief parental questionnaire completed at enrollment, and the daily recording of skin-to-skin contact performed throughout hospitalization.
The study will provide a description of skin-to-skin practice in a specialized Kangaroo Unit and may help inform future strategies to support the implementation of Kangaroo Mother Care.
Detailed description
Background
Kangaroo Mother Care (KMC) combines prolonged skin-to-skin contact between the newborn and a parent with breastfeeding support whenever possible. Evidence from randomized trials and systematic reviews has demonstrated that KMC improves physiological stability, breastfeeding, sleep organization, pain management, neurodevelopment, parent-infant bonding, and parental well-being in preterm infants.
Although KMC is widely recommended for clinically stable preterm infants, substantial variation exists in its implementation across neonatal units. Daily skin-to-skin duration differs considerably between families, even in dedicated Kangaroo Units where continuous parent-infant proximity is encouraged. The reasons for this variability remain incompletely understood.
The Kangaroo Unit at Valenciennes Hospital has routinely implemented Kangaroo Mother Care since 2005. A previous observational evaluation demonstrated that prolonged daily skin-to-skin contact could be achieved safely within this setting. However, important differences in practice between families were observed.
Rationale
Characterizing the actual duration of skin-to-skin contact and identifying factors associated with longer or shorter daily practice may improve understanding of how Kangaroo Mother Care is implemented in routine clinical care. Identifying modifiable determinants may help optimize support for families and improve organization of care within Kangaroo Units.
Study Description
This is a prospective, single-center, observational study conducted in the Kangaroo Unit of the Neonatal Department at Valenciennes Hospital.
Eligible newborns admitted to the Kangaroo Unit will receive standard clinical care according to routine practice. No study-specific intervention, treatment, or additional examination is performed.
Clinical and demographic information is obtained from routinely collected medical records. Additional information regarding parental characteristics and information received about Kangaroo Mother Care is collected using a brief questionnaire administered at enrollment. The duration of skin-to-skin contact is recorded prospectively throughout hospitalization using the routine daily documentation completed by healthcare professionals.
The primary objective is to estimate the average daily duration of skin-to-skin contact during hospitalization in the Kangaroo Unit. Secondary analyses will explore maternal, neonatal, and organizational factors that may be associated with variations in daily skin-to-skin duration.
Significance
This study will provide contemporary data describing the implementation of Kangaroo Mother Care in a specialized Kangaroo Unit. Better understanding of the factors associated with skin-to-skin practice may support future quality improvement initiatives aimed at facilitating prolonged parent-infant skin-to-skin contact during neonatal hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 11 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Unit Cohort | – | –Eligible infants admitted to the Kangaroo Unit who received routine Kangaroo Mother Care according to standard clinical practice during hospitalization. The study was observational and did not modify patient management. |
Who may qualify
- Ages
- 1 minute to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm and/or low birth weight newborns admitted to the Kangaroo Unit of Valenciennes Hospital within the first 72 hours of life.
Key inclusion criteria (2 listed)
- Preterm newborn with a gestational age between 33 weeks 0 days and 34 weeks 6 days and/or a birth weight of 1500g and 2000 g
- admitted to the Kangaroo Unit within the first 72 hours after birth
Key exclusion criteria (7 listed)
- Mother-infant separation lasting more than 72 hours after birth
- Triplet or higher-order multiple pregnancy
- Refusal of participation by one or both parents
- Cognitive impairment preventing provision of study information to a parent and/or collection of study data
- Inability to communicate with the parents (e.g. language barrier)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Average daily duration of skin-to-skin contact
Time frame: Up to 25 days (until discharge from the Kangaroo Unit)
Average duration of skin-to-skin contact per day (hours/day) during hospitalization in the Kangaroo Unit, excluding the admission and discharge days. Daily duration is routinely recorded by healthcare professionals.
1 secondary outcome
Association between parental, neonatal, socioeconomic, obstetric, postnatal and organizational characteristics and average daily duration of skin-to-skin contact
Time frame: Up to 25 days (until discharge from the Kangaroo Unit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sabine Réthoré principal investigator
Centre Hospitalier de Valenciennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity of Fetus and Low Birth Weight Baby, run by Centre Hospitalier de Valenciennes at 1 site in France.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily duration of skin-to-skin contact (time frame: Up to 25 days (until discharge from the Kangaroo Unit)). 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 5 Aug 2026.