Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: parent-pushed enteral feeding, syringe-push enteral feeding.
- Кому может быть актуально
- Состояния в реестре: Premature, Parent-Child Relations. Базовые параметры: 30 Weeks — 32 Weeks · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)
Обзор
Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child. However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown. PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.
Подробное описание
The importance of parental participation in the feeding of preterm infants has been highlighted by Gianni. In his study of 81 preterm infants in the tertiary centre , the early parental bottle feeding and the skin-to-skin contact were factors promoting withdrawal from enteral nutrition. Moreover, actively participate in care even complex, is desired by parents.
Recently, a study compared 10 parent-child dyads and showed that enteral nutrition pushed by a parent (parental nutrition, NP) in comparison of the electric syringe pump , allowed a better perception of the tube by the parents and gave them a sense of utility. The same team randomized 17 preterm infants, born after 28 WA( week amenorrhoea), to receive or not à parent-pushed enteral nutrition The child's behavior changes during nutrition were analyzed in both arms, after scoring of the videos feeding according to the NICAP® ( individualized neonatal assessment and developmental care program) method. Signs of well-being and relaxation of members were more present in case of parental involvement in the delivery of nutrition. These preliminary studies suggest that parental nutrition is well tolerated and improves the comfort of the child and parent during nutrition.
However, the impact of parental nutrition on the subsequent active nutrition and on the quality of parent-child interactions is currently unknown.
Вмешательства
- Другое parent-pushed enteral feeding
skin-to-skin enteral nutrition pushed by the parent - Другое syringe-push enteral feeding
skin to skin nutrition with syringe pump
Первичные конечные точки
- behavioural interactions (visual, vocal, mimic) [Срок оценки: 34 (W) weeks of gestational age]
Вторичные конечные точки (12)
- Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS) [Срок оценки: at Month 4]
- Edinburgh Postpartum Depression Risk Rating Scale (EPDS) [Срок оценки: at inclusion, at 32, 34 and 37 weeks of gestation]
- Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU) [Срок оценки: at 32, 34, and 37 weeks of gestation]
- Number of desaturation [Срок оценки: every day betwenn 32 and 34 weeks of gestation]
- Number of vomiting [Срок оценки: every day between 32 and 34 weeks of gestation]
- Exit age on return home [Срок оценки: through study completion, an average of 41 week of gestation]
- Parental time in hours [Срок оценки: at 34 week of gestation and 37 week of gestation, calculated over 7 days]
- Number of meals and baths given by parents [Срок оценки: from 32 week of gestation to 37 week of gestation]
- Duration of transition from passive to active feeding in number of days [Срок оценки: from 32 week of gestation to 37 week of gestation]
- Average duration (minutes) of feeding/feeding [Срок оценки: at 37 week of gestation]
- Number and duration of skin-to-skin sessions in minutes [Срок оценки: from inclusion to exit of service ( up to 45 week of gestation)]
- Duration of breastfeeding in number of days. [Срок оценки: from 32 week of gestation to 37 week of gestation]
Критерии участия
Критерии включения
Children born before 30 SA Age of child at start of study: 32 SA
Критерии исключения
- Child with ongoing infection, neurological pathology More than one desaturation and/or bradycardia per hour within 12 last hours Balloon ventilation in last 12 hours
- Medical contraindication to oral nutrition
- Intubated child
- Parents with a disabling mental illness
- Parents not available
- Minor parents
- Parents under guardianship or protection of justice
- Refusal to sign consent
- Parents not affiliated with a social security system
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
- Простое слепое
- Основная цель
- Другое
Центры проведения
Франция · 1 центр
- Centre Hospitalier Intercommunal Créteil — Créteil
Идентификаторы
NCT: NCT05313464 · PREMIAM