Effect of Care Package on Duration of Stay and Physiological Parameters in Non-invasive Mechanical Ventilation
Condition: Care
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The sample size was determined by power analysis. The power of the sample in the research was
      calculated with the G*Power 3.1 program. While the type I error amount was 0.05, the power of
      the test = 0.85 (α=0.05, 1-β=0.84, effect size: 0.7), the minimal sample size was calculated
      as 60 newborns (30 newborns in each group). 40 newborns were included in the study. The study
      was completed by including 40 newborns in the neonatal intervention group (the group in which
      temporary tachypnea of the newborn care package was applied) and 40 newborns in the control
      group.

      Sample selection criteria; of the newborn;

        -  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

      Exclusion criteria from the sample;

        -  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.

      The "Data Collection and Daily Monitoring Form", in which some descriptive characteristics of
      the baby and physiological parameter measurements were evaluated, was used as a data
      collection tool. In addition, necessary devices (monitor and sphygmomanometer, stopwatch,
      thermometer, blood gas device) were used to control physiological parameters.

      Care Package for Transient Tachypnea (TTN) Current literature was scanned while determining
      the parameters included in the care package applied in case of temporary tachypnea of the
      newborn. Expert opinion was taken for the content of the care package prepared in line with
      the literature (2 academic nurses, 2 clinical nurses and 1 specialist physician). Care
      Package consists of 5 items.

        1. Heating and humidifying the oxygen-air mixture given to the baby

        2. Stopping the baby's feeding and switching to open drainage with orogastric tube (OGS)

        3. Application of postural drainage, percussion and vibration 4 times a day for an average
           of 10-15 minutes

        4. If necessary, aspirate the baby

        5. Changing the position given to the baby (to increase oxygenation) periodically (every 3
           hours)

      The newborns included in the study were divided into two groups: intervention and control
      groups. Between the dates of the research, the first 40 newborns who met the sampling
      criteria were included in the control group (who received nursing care in line with the
      routine care protocol of the clinic), and the 40 newborns who met the sample criteria (who
      received nursing care in line with the routine care protocol of the clinic) were included in
      the control group, and the 40 newborns who met the sample criteria were given training on the
      care package after the nurses working in the clinic. (in addition to the maintenance package
      application) were included in the intervention group.

      To prevent the research groups from being influenced by each other, the study started with
      the control group first. Nursing care was applied to the control group in line with the
      routine care protocol of the clinic. After the control group data were collected, all nurses
      working in the clinic were given training on the application of the neonatal temporary
      tachypnea care package to be applied to the intervention group. The training was given within
      the scope of a presentation prepared by the researcher in the staff room within the clinic.
      The training was planned according to the nurses' working hours and was planned in 5 separate
      groups according to the day they were in the hospital and their available hours. The training
      lasted approximately 20 minutes. After the training was completed, care package applications
      for the intervention group started.

      A data collection and daily monitoring form was filled out for newborns in both groups
      immediately after admission to the intensive care unit. The newborn was placed in a
      pre-heated incubator and monitored. A hydrocolloid strip tape was cut and pasted in a T shape
      on his nose and he was connected to the mechanical ventilator via a ram cannula interface. An
      oragastric catheter was inserted into the stomach (with a 10ml syringe) and open drainage was
      performed. Blood samples requested by the physician were taken and a vascular access was
      established. The patient's intravenous fluid was started. After the newborn was stabilized,
      care practices were performed every three hours in line with the clinical routine care
      protocol. Neonatal temporary tachypnea care package was applied to the newborns in the
      intervention group in addition to the clinical routine until they were weaned from mechanical
      ventilation support.

      Evaluation of Data The data were evaluated with appropriate statistical analysis in the SPSS
      21.0 program. Number, percentage, mean and standard deviation were used as descriptive
      statistical methods in the evaluation of the data. Frequency and percentage distributions of
      the data are given. In the study, intra-group measurements were made with correlated sample
      one-way analysis of variance, and inter-group measurements were made with independent group t
      test. Bonferonni test was applied to determine which group caused the difference. 0.05 was
      used as the significance level, and if p<0.05 it was stated that there was a significant
      difference, and if p>0.05 it was stated that there was no significant difference.
    

Intervention name(s): The group to which a care package was applied in addition to the clinical routine care protocol)
Intervention type(s): Behavioral
Intervention description(s): Intervention Group:
Immediately after the newborn's admission to the intensive care unit, mechanical ventilation mode, physiological parameters, blood gas results and descriptive characteristics of the baby were recorded in the "Data Collection and Daily Monitoring Form".
In addition to the routine care practices of the clinic (every 3 hours / 8 times a day), the newborn's temporary tachypnea care package was applied. Postural drainage, percussion and vibration were applied 4 times a day for an average of 10-15 minutes.
Mechanical ventilation mode and physiological parameters were recorded one hour after 4 daily maintenance applications.
Blood gas parameters were evaluated immediately before and 1 hour after the newborn was separated from mechanical ventilation.
Physiological parameters were recorded again 1 hour after the first routine nursing care after the newborn was separated from mechanical ventilation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: control grup and intervention grup
Masking: None (Open Label)
Primary purpose: Prevention