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CareNCT06189989

Effect of Care Package on Duration of Stay and Physiological Parameters in Non-invasive Mechanical Ventilation

A study testing The group to which a care package was applied in addition to the clinical routine care protocol) in people with Care, run by Okan University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 36 to 41 weeksHealthy volunteers can take part
Conditions the study is for
Care
What is being tested?
The group to which a care package was applied in addition to the clinical routine care protocol)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Jan 2022to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 36 to 41 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • -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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Esma Şeker

    Istanbul, 34230

Other trials in Turkey (Türkiye)

About this study

Official title: 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

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.

Read more

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.

Read the 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.

Conditions
Care
Being tested
The group to which a care package was applied in addition to the clinical routine care protocol)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The group to which a care package was applied in addition to the clinical routine care protocol)Behavioural

    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.
Study groups in NCT06189989
Study groupRoleWhat they receive
Intervention GroupExperimentalIn addition to the clinical routine care, the newborn temporary tachypnea care package that we created was applied to the babies in the intervention group. Physiological parameters and blood gas results were recorded.
Receives: Behavioral: The group to which a care package was applied in addition to the clinical routine care protocol)
Control groupNo interventionOnly clinical routine care practices were applied to the babies in the control group. Physiological parameters and blood gas results were recorded.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart rate Vital Signs

    Heart rate (beats/minute) were evaluated

    Measured: 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.

  2. Respiratory Rate Vital Signs

    Respiratory Rate (breaths/minute) were evaluated

    Measured: 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.

  3. Body temperature Vital Signs

    Body temperature (°C) were evaluated

    Measured: 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.

  4. Oxygen saturation Vital Signs

    Oxygen saturation (%) were evaluated

    Measured: 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.

  5. Blood pressure Vital Signs

    Blood pressure (mmHg) were evaluated

    Measured: 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.

  6. blood gas pH value :

    blood gas H iyon

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

  7. blood gas PCO2 value

    blood gas PCO2 (mmHg) were evaluted

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

  8. blood gas HCO3 value

    blood gas HCO3 (mEq/L) were evaluted

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

  9. blood gas PaO2 value

    blood gas PaO2 (mmHg)were evaluted

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

  10. blood gas SaO2 value :

    blood gas SaO2 (mmHg)were evaluted

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

  11. blood gas lactat value

    blood gas lactat (mmol/L) were evaluted

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

  12. blood gas BE value

    blood gas BE(mmol/L) were evaluted

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

Secondary outcomes (3)
  1. Total duration of mechanical ventilation stay

    in total hours

    Measured: 1 hour after discharge from intensive care

  2. Total duration of stay in intensive care unit duration of transition to oral feeding were evaluated).

    in total hours

    Measured: 1 hour after discharge from intensive care

  3. Total duration of transition to oral feeding were

    in total hours

    Measured: 1 hour after discharge from intensive care

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start30 Jan 2022
  3. Primary completion30 Oct 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
control grup and intervention grup
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06189989
Sponsor's protocol ID
OkanÜniversitesiEsmaŞeker001
Status last verified
Dec 2023
First submitted
9 Dec 2023
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The group to which a care package was applied in addition to the clinical routine care protocol) in people with Care, run by Okan University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart rate Vital Signs (time frame: 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.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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