An interventional study of actimeters and questionnaires in Co-spleeping, Spleeping Quality and Newborn, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
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.
Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Secondary exclusion criteria:
Device: actimeters · Other: questionnaires
Device: actimeters · Other: questionnaires
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.
During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills
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.
Time frame: 4 months
total sleep time of newborn in co-sleeping group
Evaluate the effect of co-sleeping on total sleep time of newborn
Time frame: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated by total sleep time
Time frame: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with total sleep time
Time frame: 4 months
effect of co-sleeping on parental anxiety
During their stay in the maternity unit, the mothers will complete questionnaires used in routine care to assess anxiety and parenting skills.
Time frame: 4 months
correlation between sleeping arrangements and continued breastfeeding duration
Time frame: 4 months
Number of newborns with sleeping pattern modifications
Observe changes in the newborn's sleeping pattern once he/she returns home;
Time frame: 4 months
Number of mothers with modified quality of sleep
changes in the quality of sleep experienced by the mother once she has returned home during the child's first months of life
Time frame: 4 months
complications related to breastfeeding
complications related to breastfeeding that could have an impact on the mother's sleep quality.
Time frame: 4 months
sleep quality of breastfeeding mother
sleep quality of and breastfeeding mother is evaluated with total sleep time
Time frame: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with frequency of nocturnal awakenings
Time frame: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with duration of nocturnal awakenings
Time frame: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with sleep latency
Time frame: 4 months
sleep quality of newborn
sleep quality of newborn is evaluated with duration of sleep phases.
Time frame: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with frequency of nocturnal awakenings
Time frame: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with duration of nocturnal awakenings
Time frame: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with sleep latency
Time frame: 4 months
correlation between temperature and sleep quality
Sleep quality is evaluated with duration of sleep phases.
Time frame: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with frequency of nocturnal awakenings
Time frame: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with duration of nocturnal awakenings
Time frame: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with sleep latency
Time frame: 4 months
sleep quality of breastfeeding mother
sleep quality of breastfeeding mother is evaluated with duration of sleep phases.
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire, Amiens