Идёт набор NCT06594458

New Procedure to Reduce Mother-newborn Separation

Без фазы С лечением Neonatal Disease

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: Observation of newborn with respiratory distress in the delivery room.
Кому может быть актуально: Состояния в реестре: Neonatal Disease. Базовые параметры: 1 Minute — 3 Days · 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: Италия
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

To Reduce the Separation of the Mother-newborn Dyad in the First Day of Life Through the Implementation of a New Procedure in the Delivery Room

Обзор

The goal of this single-centre interventional study without medication neither device (for procedure) is to limit the separation between mother and newborn by implementing a new procedure for the management of the newborn with respiratory distress in the delivery room. The main questions it aims to answer are: * Is it possible to reduce Neonatal Intensive Care Unit admissions within 24 hours of life by applying this new procedure, thus limiting separation between mother and newborn? * Does the implementation of this procedure, reducing mother-newborn separation, improves the rate of exclusive breastfeeding? Newborns with respiratory distress at birth will be evaluated in the delivery room in a dedicated pre-heated incubator, providing additional oxygen if necessary. In case of improvement they will be reunited with the mother, in case of worsening a thoracic ultrasound will be performed to assess the severity and possible hospitalization in Neonatal Intensive Care Unit

Подробное описание

This procedure provides that newborn infants, who at 15 minutes of life manifest tachypnea or respiratory distress (that responds to supplementary oxygen with FiO2 \<30% and without the need for mechanical ventilation) they are placed in a preheated incubator with the required oxygen concentration (if necessary) and carefully monitored by medical and nursing clinicians. A clinical evaluation will be carried out every 15 minutes, with the detection of vital parameters, such as heart rate, oxygen saturation and respiratory rate. In case of clinical improvement and suspension of oxygen therapy, the newborn will be transferred to the Neonatal Observation Ward to perform multiparameter monitoring of vital signs up to 6 hours of life and then be reunited with the mother. In case of clinical worsening, a bedside thoracic ultrasound will be carried out and depending on the result and the Lung Ultrasonography score, it will be evaluated whether to continue the observation in the delivery room or hospitalize the newborn in the Neonatal Care, Neonatal Sub-Intensive Care or Neonatal Intensive care Units.

Вмешательства

Процедура Observation of newborn with respiratory distress in the delivery room
Newborn manifesting tachypnea or respiratory distress at birth (that responds to supplementary oxygen with FiO2 \<30% and without the need for mechanical ventilation) are placed in a preheated incubator with the required oxygen concentration (if necessary) and carefully monitored by medical and nursing clinicians. A clinical evaluation will be carried out every 15 minutes, with the detection of vital parameters. In case of clinical improvement and suspension of oxygen therapy, the newborn will b

Первичные конечные точки

Limit the separation between mother and newborn [Срок оценки: 3 hours]

Вторичные конечные точки (1)

Exclusive Breastfeeding rate [Срок оценки: 3 days]

Критерии участия

Критерии включения

Infants born by elective cesarean section, with gestational age ≥34 weeks, weight at birth ≥2000 grams, manifesting mild respiratory distress with need for oxygen at FiO2 ≤30%
Signature by both parents of an informed consent