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Effect of Three-Stair-Position on Improvement of Apnea of Prematurity

Primary Purpose

Apnea of Prematurity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Three-stair-position
Head elevated tilt position group
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apnea of Prematurity focused on measuring head elevated position, preterm, three-stair-position

Eligibility Criteria

undefined - 3 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. preterm, gestational age(GA) <34weeks determined by obstetric ultra-sonogram and clinical examination
  2. steady vital signs
  3. Apgar scores were greater than or equal to 3 at 1min and greater than or equal to 5 at 5 minutes.

Exclusion Criteria:

  1. infants with congenital malformation,for example Congenital Heart Disease, Diaphragmatic hernia, Hirschsprung,etc
  2. Infants who need special position and/or intervention (gastroschisis or umbilical catheterization)
  3. weight<1000g
  4. infants who were undertaking conventional invasive mechanical ventilation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Three-stair-position group

    head elevated tilt position group

    Arm Description

    The infants in the study group (n=72) received three-stair-position (TSP) intervention (head up 15°) for a week.

    The control group(n=72)received head elevated tilt position (HETP) intervention (head up 15°) for a week.

    Outcomes

    Primary Outcome Measures

    The rate of AOP
    Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%

    Secondary Outcome Measures

    Number of Participants who need treatments
    Treatments of AOP include stimulation, nasal cannula oxygen, pressurized oxygen, continuous positive airway pressure (CPAP), invasive mechanical ventilation, medication (pulmonary surfactant, aminophylline).
    Adverse events during feeding
    Times of milk retention
    Number of Participants with distension
    Distension was diagnosed by a doctor and a nurse.
    Heart rate
    Number of Participants with Adverse Events
    amount of retention milk
    respiratory rate
    SPO2

    Full Information

    First Posted
    December 25, 2014
    Last Updated
    January 20, 2015
    Sponsor
    Children's Hospital of Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02346864
    Brief Title
    Effect of Three-Stair-Position on Improvement of Apnea of Prematurity
    Official Title
    Effect of Three-Stair-Position on Improvement of Apnea of Prematurity and Feeding Performance in Prematurity: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Children's Hospital of Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is evaluating the effectiveness of three-stair-position (TSP) on the rate of Apnea of Prematurity (AOP), the feeding performance and the vital signs.
    Detailed Description
    Apnea of Prematurity (AOP) is common critical symptoms of preterm infants with great harm for prematurity. Recurrent apnea may lead to brain damage caused by hypoxia, affecting the nervous system, even threatening life (1, 2). Therefore, choosing an intervention which can prevent and reduce occurrence of AOP with fewer side effects is an important issue that should be closely watched by neonatal intensive care unit (NICU) health care. Prone position is the forefront treatment due to its simple, economic and non-invasive. In clinic, it includes horizontal prone position (HPP), Head elevated tilt 15 ° prone position (HETP) and three-step-prone position (TSP)(3).Many studies have shown that HETP can allow thoracic volume increased and make abdominal movement more coordinated in preterm children, and then it is more favorable than the HPP on improving respiratory function. So HETP has been a routine position in NICU instead of HPP (4, 5). HETP, however, always make the babies slide to the foot of the bed resulting in airway obstruction. Therefore, scholars have proposed TSP which should prevent this phenomenon (6). In the study, the effectiveness of TSP on improvement of AOP will be evaluated trying to find a more suitable position for preterm infants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Apnea of Prematurity
    Keywords
    head elevated position, preterm, three-stair-position

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    144 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Three-stair-position group
    Arm Type
    Experimental
    Arm Description
    The infants in the study group (n=72) received three-stair-position (TSP) intervention (head up 15°) for a week.
    Arm Title
    head elevated tilt position group
    Arm Type
    Other
    Arm Description
    The control group(n=72)received head elevated tilt position (HETP) intervention (head up 15°) for a week.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Three-stair-position
    Intervention Description
    Infants in the TSP group received three-stair-prone position. Implementation steps were as following: 1) produced pad of three-stair-prone position the total height of which should be the same height as the head elevated 15 °. 2) Placed the infants on the pad with head on the highest ladder, chest on the second step and leg on the third step, bending the knees to the chest
    Intervention Type
    Behavioral
    Intervention Name(s)
    Head elevated tilt position group
    Intervention Description
    Infants in the HETP group were allowed head up 15 ° prone position using a protractor with head to one side, arms against the sides of the body naturally bending, knees bent to the chest.
    Primary Outcome Measure Information:
    Title
    The rate of AOP
    Time Frame
    7 Days
    Title
    Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%
    Time Frame
    7 Days
    Secondary Outcome Measure Information:
    Title
    Number of Participants who need treatments
    Description
    Treatments of AOP include stimulation, nasal cannula oxygen, pressurized oxygen, continuous positive airway pressure (CPAP), invasive mechanical ventilation, medication (pulmonary surfactant, aminophylline).
    Time Frame
    7 Days
    Title
    Adverse events during feeding
    Time Frame
    7 Days
    Title
    Times of milk retention
    Time Frame
    7 Days
    Title
    Number of Participants with distension
    Description
    Distension was diagnosed by a doctor and a nurse.
    Time Frame
    7 Days
    Title
    Heart rate
    Time Frame
    7 Days
    Title
    Number of Participants with Adverse Events
    Time Frame
    7 Days
    Title
    amount of retention milk
    Time Frame
    7 Days
    Title
    respiratory rate
    Time Frame
    7 Days
    Title
    SPO2
    Time Frame
    7 Days

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    3 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: preterm, gestational age(GA) <34weeks determined by obstetric ultra-sonogram and clinical examination steady vital signs Apgar scores were greater than or equal to 3 at 1min and greater than or equal to 5 at 5 minutes. Exclusion Criteria: infants with congenital malformation,for example Congenital Heart Disease, Diaphragmatic hernia, Hirschsprung,etc Infants who need special position and/or intervention (gastroschisis or umbilical catheterization) weight<1000g infants who were undertaking conventional invasive mechanical ventilation.

    12. IPD Sharing Statement

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    Effect of Three-Stair-Position on Improvement of Apnea of Prematurity

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