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
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
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.
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
NCT ID
NCT02346864
First Posted
December 25, 2014
Last Updated
January 20, 2015
Sponsor
Children's Hospital of Fudan University
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
Learn more about this trial
Effect of Three-Stair-Position on Improvement of Apnea of Prematurity
We'll reach out to this number within 24 hrs