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CompletedNCT07747870PAP-UKUpdated Aug 5, 2026

Daily Skin-to-Skin Contact Duration in Preterm and Low Birth Weight Infants Admitted to a Kangaroo Care Unit

An observational study in Prematurity of Fetus and Low Birth Weight Baby, sponsored by Centre Hospitalier de Valenciennes. Completed at 1 site in France. Open to participants aged 1 Minute to 72 Hours. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Centre Hospitalier de Valenciennes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
1 Minute to 72 Hours
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Centre Hospitalier de Valenciennes is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 72 Hours
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Preterm and/or low birth weight newborns admitted to the Kangaroo Unit of Valenciennes Hospital within the first 72 hours of life.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (actual)
Target follow-up
11 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Up to 25 days (until discharge from the Kangaroo Unit)

07

Study locations

1 site
  • Centre Hospitalier de Valenciennes
    Valenciennes, 59300, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07747870
Lead sponsor
Centre Hospitalier de Valenciennes
Responsible party
Sponsor
First posted
Aug 5, 2026
Start date
Jun 10, 2021
Primary completion
Mar 13, 2025
Completion
Mar 22, 2025
Last update
Aug 5, 2026

Study contacts

Sabine Réthoré
principal investigator · Centre Hospitalier de Valenciennes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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