跳至主要内容
临床试验/NCT06189989
NCT06189989已完成不适用

The Effect Of The Care Package Applıed To Babıes Whıch Are Monıtored Wıth Temporary Follow-Up Of The Newborn In The Newborn Intensıve Care Unıt On The Duratıon Of Stay In Non-Invasıve Mechanıcal Ventılatıon And Physıologıcal Parameters

Okan University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Oxygen saturation Vital Signs

研究概览

简要总结

Temporary tachypnea of the newborn can be improved with minimal respiratory support and nursing care given to babies within the first 72 hours of life. Nursing care practices; It includes pain management, aspiration, moistening and warming of the airways, skin care, nutrition, body temperature regulation, positioning and chest physiotherapy practices.

Physiotherapy practices, when applied in accordance with the criteria, can reduce the newborn's respiratory problems and shorten the hospital stay. Although it has been reported that chest physiotherapy practices have a clinically positive effect on newborns, studies in this field are insufficient.

Nowadays, the concept of care package is frequently used, especially in areas where nursing care is very important, such as intensive care. Implementation of care packages in patient care increases the quality of care by ensuring standardization in the clinic. It also contributes to observing improvements in health practices. The positive results of the use of care packages in their application areas and the lack of care package application in babies monitored with temporary tachypnea of the newborn when the literature was scanned have led to the necessity of conducting studies in this field.

The study was planned as a semi-experimental (non-randomized) control group study to examine the effect of the care package applied to babies monitored with temporary tachypnea of the newborn in the neonatal intensive care unit on the duration of stay in noninvasive mechanical ventilation and physiological parameters.

详细描述

This study was carried out as a semi-experimental control group study to examine the effect of the care package applied to babies monitored with temporary tachypnea of the newborn in the Neonatal Intensive Care Unit of Istanbul Esenler Gynecology and Children's Hospital, on the duration of stay in noninvasive mechanical ventilation and physiological parameters.

Hypothesis 1 (H1): The care package applied to babies monitored with transient tachypnea of the newborn shortens the duration of stay in noninvasive mechanical ventilation.

Hypothesis 2 (H2): The care package applied to babies monitored with transient tachypnea of the newborn positively affects physiological parameters.

Hypothesis 3 (H3): The care package applied to babies monitored with transient tachypnea of the newborn positively affects blood gas parameters.

The research was conducted in the Neonatal Intensive Care Unit of Esenler Gynecology and Children's Hospital between January 2023 and October 2023.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
36 Weeks 至 41 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Being 36 weeks or above according to gestational age
  • Birth weight being 1500 grams and above
  • Receive noninvasive mechanical ventilation support
  • Feeding via orogastric tube
  • Parents' consent for the baby to be included in the study

排除标准

  • Those with pneumothorax and suspicion
  • Those with cranial bleeding or any suspicion of bleeding
  • Babies with congenital anomalies affecting breathing
  • Babies who are reconnected to mechanical ventilation after being weaned off noninvasive mechanical ventilation
  • Babies with neurological diseases (no neurological problems (hypotonia, hypertonic etc.), no history of convulsions, not using sedative drugs, normal cranial USG,
  • Babies with any fractures (clavicle, femur, etc.) were excluded from the sample.

结局指标

主要结局

Oxygen saturation Vital Signs

时间窗: It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

Oxygen saturation (%) were evaluated

blood gas HCO3 value

时间窗: It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

blood gas HCO3 (mEq/L) were evaluted

blood gas SaO2 value :

时间窗: It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

blood gas SaO2 (mmHg)were evaluted

Heart rate Vital Signs

时间窗: It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

Heart rate (beats/minute) were evaluated

Blood pressure Vital Signs

时间窗: It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

Blood pressure (mmHg) were evaluated

Respiratory Rate Vital Signs

时间窗: It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

Respiratory Rate (breaths/minute) were evaluated

blood gas pH value :

时间窗: It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

blood gas H iyon

blood gas PaO2 value

时间窗: It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

blood gas PaO2 (mmHg)were evaluted

Body temperature Vital Signs

时间窗: It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

Body temperature (°C) were evaluated

blood gas BE value

时间窗: It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

blood gas BE(mmol/L) were evaluted

blood gas PCO2 value

时间窗: It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

blood gas PCO2 (mmHg) were evaluted

blood gas lactat value

时间窗: It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

blood gas lactat (mmol/L) were evaluted

次要结局

  • Total duration of mechanical ventilation stay(1 hour after discharge from intensive care)
  • Total duration of stay in intensive care unit duration of transition to oral feeding were evaluated).(1 hour after discharge from intensive care)
  • Total duration of transition to oral feeding were(1 hour after discharge from intensive care)

研究者

发起方
Okan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esma Şeker

Esma Şeker

Okan University

研究点 (2)

Loading locations...

相似试验