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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• total sleep time in both groups [Срок оценки: 4 months]

Вторичные конечные точки (12)

• total sleep time of newborn in co-sleeping group [Срок оценки: 4 months]
• sleep quality of newborn [Срок оценки: 4 months]
• correlation between temperature and sleep quality [Срок оценки: 4 months]
• effect of co-sleeping on parental anxiety [Срок оценки: 4 months]
• correlation between sleeping arrangements and continued breastfeeding duration [Срок оценки: 4 months]
• Number of newborns with sleeping pattern modifications [Срок оценки: 4 months]
• Number of mothers with modified quality of sleep [Срок оценки: 4 months]
• complications related to breastfeeding [Срок оценки: 4 months]
• sleep quality of breastfeeding mother [Срок оценки: 4 months]
• sleep quality of newborn [Срок оценки: 4 months]
• sleep quality of newborn [Срок оценки: 4 months]
• sleep quality of newborn [Срок оценки: 4 months]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU Amiens Picardie — Amiens

Идентификаторы

NCT: NCT07525830 · PI2025_843_0007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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