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NCT Number: NCT07525830

Optimizing Sleep Maternal-Offspring Bonding and Sleep in the Maternity Ward

The quality of sleep in maternity wards is crucial for the mental and physical health of the mother, as well as for the development of secure mother to infant bonding. The introduction of "co-dodo" cribs, although scarcely studied, may influence sleep quality in both the mother and the newborn infant. Objective : This study aims at evaluating the impact of a co-dodo crib on the sleep quality of the newborn infant, her mother and the mother-infant bonding, compared to a control group with mother using a standard crib.

This observational, randomized, controlled, multicenter study will include adult mother, breastfeeding and hospitalized in maternity wards after full-term delivery (≥ 37 weeks of gestation). Participant will be randomly assigned in a 1:1 ratio to receive either a co-dodo crib or a standard crib for their newborn infant during their maternity STAI-Y. Actigraphic data will be used for non-invasive sleep assessment in both the newborn infant and the mother. Validated self-reported questionnaires will evaluate maternal stress, sleep quality, post-partum depression risk and mother-infant bonding. • Hypothesis : We hypothesize that using a co-dodo crib compared to a standard crib may improve the newborn and mother sleep quality, decrease the mother stress and enhance the mother to infant bonding.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Pierre TOURNEUX, PhD

CONTACT

[email protected]

+33322668652

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maternal inclusion criteria:
  • Mother over 18 years of age;
  • Mother for whom vaginal delivery is planned
  • Mother who has chosen to breastfeed exclusively;
  • Mother who has a single pregnancy;
  • Mother with no history of sleep disorders.
  • Mother able to understand, read and speak French or, failing that, who has someone in her immediate circle who can understand, read and speak French;
  • Mother affiliated to the social security system;
  • Having signed the consent to participate in the study
  • Newborn inclusion criteria:
  • Newborns born at term, i.e. ≥ 37+0 weeks of amenorrhea (SA).

Exclusion criteria

  • Non-inclusion criterion relating to the mother:
  • Mother for whom a cesarean section is scheduled
  • Mother under legal protection ;
  • Mother presenting with an acute or chronic non-stabilized condition;
  • Mother with a history of sleep disorders;
  • Mother exposed to substances that can alter sleep (alcohol, sedative drugs).

Secondary exclusion criteria:

  • Mother who gave birth by emergency cesarean section
  • Mother with a major post-partum medical complication requiring follow-up in a unit other than the maternity unit;
  • Newborn with a major medical complication requiring follow-up in a unit other than the maternity unit.

Treatment and study plan

actimeters

Device

Patients and their newborns will be randomized into two groups: standard cradle or co-sleeping cradle.

Once the cradle has been allocated, they will be given two actimeters: one for the mother (a bracelet worn on the wrist) and a second for the newborn (a bracelet worn on the ankle above the pyjamas).

Recording of sleep quality data will begin as soon as the actimeters are worn. At the end of their stay in the maternity ward (3 days ± 2 days), the actimeters will be returned to us and the data downloaded into the dedicated software.

questionnaires

Other

During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills

Primary outcomes

  1. total sleep time in both groups

    Time frame: 4 months

    impact of co-sleeping on the total sleep time of breastfeeding mothers, compared with a control group in which the breastfeeding mothers use a standard cradle.

Secondary outcomes

  1. total sleep time of newborn in co-sleeping group

    Time frame: 4 months

    Evaluate the effect of co-sleeping on total sleep time of newborn

  2. sleep quality of newborn

    Time frame: 4 months

    sleep quality of newborn is evaluated by total sleep time

  3. correlation between temperature and sleep quality

    Time frame: 4 months

    Sleep quality is evaluated with total sleep time

  4. effect of co-sleeping on parental anxiety

    Time frame: 4 months

    During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills.

  5. correlation between sleeping arrangements and continued breastfeeding duration

    Time frame: 4 months

  6. Number of newborns with sleeping pattern modifications

    Time frame: 4 months

    Observe changes in the newborn's sleeping pattern once he/she returns home;

  7. Number of mothers with modified quality of sleep

    Time frame: 4 months

    changes in the quality of sleep experienced by the mother once she has returned home during the child's first months of life

  8. complications related to breastfeeding

    Time frame: 4 months

    complications related to breastfeeding that could have an impact on the mother's sleep quality.

  9. sleep quality of breastfeeding mother

    Time frame: 4 months

    sleep quality of and breastfeeding mother is evaluated with total sleep time

  10. sleep quality of newborn

    Time frame: 4 months

    sleep quality of newborn is evaluated with frequency of nocturnal awakenings

  11. sleep quality of newborn

    Time frame: 4 months

    sleep quality of newborn is evaluated with duration of nocturnal awakenings

  12. sleep quality of newborn

    Time frame: 4 months

    sleep quality of newborn is evaluated with sleep latency

  13. sleep quality of newborn

    Time frame: 4 months

    sleep quality of newborn is evaluated with duration of sleep phases.

  14. correlation between temperature and sleep quality

    Time frame: 4 months

    Sleep quality is evaluated with frequency of nocturnal awakenings

  15. correlation between temperature and sleep quality

    Time frame: 4 months

    Sleep quality is evaluated with duration of nocturnal awakenings

  16. correlation between temperature and sleep quality

    Time frame: 4 months

    Sleep quality is evaluated with sleep latency

  17. correlation between temperature and sleep quality

    Time frame: 4 months

    Sleep quality is evaluated with duration of sleep phases.

  18. sleep quality of breastfeeding mother

    Time frame: 4 months

    sleep quality of breastfeeding mother is evaluated with frequency of nocturnal awakenings

  19. sleep quality of breastfeeding mother

    Time frame: 4 months

    sleep quality of breastfeeding mother is evaluated with duration of nocturnal awakenings

  20. sleep quality of breastfeeding mother

    Time frame: 4 months

    sleep quality of breastfeeding mother is evaluated with sleep latency

  21. sleep quality of breastfeeding mother

    Time frame: 4 months

    sleep quality of breastfeeding mother is evaluated with duration of sleep phases.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre TOURNEUX, Pr

CONTACT

[email protected]

33+322088051

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: COSMOS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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