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

NCT07525830 | Recruiting

• 1 other identifier: PI2025_843_0007
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• total sleep time in both groups

  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.

  4 months

Secondary Outcomes (21)

• total sleep time of newborn in co-sleeping group

  4 months

• sleep quality of newborn

  4 months

• correlation between temperature and sleep quality

  4 months

• effect of co-sleeping on parental anxiety

  4 months

• correlation between sleeping arrangements and continued breastfeeding duration

  4 months

Study Arms (2)

standard cradle

ACTIVE COMPARATOR

Device: actimeters; Other: questionnaires

co-sleeping cradle

EXPERIMENTAL

Device: actimeters; Other: questionnaires

Interventions

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.

co-sleeping cradle; standard cradle

questionnaires OTHER

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

co-sleeping cradle; standard cradle

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: mother and newborn
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Newborns born at term, i.e. ≥ 37+0 weeks of amenorrhea (SA).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Pierre TOURNEUX, Pr

CONTACT

33+322088051; Tourneux.pierre@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 13, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)