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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07525830
Acronym
COSMOS
Enrollment
132
Registered
2026-04-13
Start date
2026-02-16
Completion date
2027-08-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bonding, Breastfeeding Mothers, Co-spleeping, Newborn, Spleeping Quality

Keywords

Co-spleeping, spleeping quality, newborn, breastfeeding mothers, bonding

Brief summary

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.

Interventions

DEVICEactimeters

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.

OTHERquestionnaires

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

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
total sleep time in both groups4 monthsimpact 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

MeasureTime frameDescription
total sleep time of newborn in co-sleeping group4 monthsEvaluate the effect of co-sleeping on total sleep time of newborn
sleep quality of newborn4 monthssleep quality of newborn is evaluated by total sleep time
correlation between temperature and sleep quality4 monthsSleep quality is evaluated with total sleep time
effect of co-sleeping on parental anxiety4 monthsDuring their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills.
correlation between sleeping arrangements and continued breastfeeding duration4 months
Number of newborns with sleeping pattern modifications4 monthsObserve changes in the newborn's sleeping pattern once he/she returns home;
Number of mothers with modified quality of sleep4 monthschanges in the quality of sleep experienced by the mother once she has returned home during the child's first months of life
complications related to breastfeeding4 monthscomplications related to breastfeeding that could have an impact on the mother's sleep quality.
sleep quality of breastfeeding mother4 monthssleep quality of and breastfeeding mother is evaluated with total sleep time

Countries

France

Contacts

CONTACTPierre TOURNEUX, Pr
Tourneux.pierre@chu-amiens.fr33+322088051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026