Apnea of PrematurityNCT02346864
Effect of Three-Stair-Position on Improvement of Apnea of Prematurity
A study testing Three-stair-position and Head elevated tilt position group in people with Apnea of Prematurity, run by Children's Hospital of Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Apnea of Prematurity
- What is being tested?
- Three-stair-position and Head elevated tilt position group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Dec 2014
- 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 Up to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effect of Three-Stair-Position on Improvement of Apnea of Prematurity and Feeding Performance in Prematurity: A Randomized Control Trial
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.
Read the 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.
- Conditions
- Apnea of Prematurity
- Being tested
- Three-stair-position, Head elevated tilt position group
- Keywords
- head elevated position, preterm, three-stair-position
- Medical subject headings
- Apnea, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-stair-positionBehavioural
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
Head elevated tilt position groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Three-stair-position group | Experimental | The infants in the study group (n=72) received three-stair-position (TSP) intervention (head up 15°) for a week. Receives: Behavioral: Three-stair-position |
| head elevated tilt position group | Other | The control group(n=72)received head elevated tilt position (HETP) intervention (head up 15°) for a week． Receives: Behavioral: Head elevated tilt position group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of AOP
Measured: 7 Days
Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%
Measured: 7 Days
Secondary outcomes (9)
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).
Measured: 7 Days
Adverse events during feeding
Measured: 7 Days
Times of milk retention
Measured: 7 Days
Number of Participants with distension
Distension was diagnosed by a doctor and a nurse.
Measured: 7 Days
Heart rate
Measured: 7 Days
Number of Participants with Adverse Events
Measured: 7 Days
amount of retention milk
Measured: 7 Days
respiratory rate
Measured: 7 Days
SPO2
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startDec 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea of PrematurityStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346864
- Sponsor's protocol ID
- FNF201221
- Status last verified
- Jan 2015
- First submitted
- 25 Dec 2014
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Three-Stair-Position on Improvement of Apnea of Prematurity and Feeding Performance in Prematurity: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02346864
- Acronym / sponsor ID
- FNF201221
- Conditions
- Apnea of Prematurity
- Keywords
- head elevated position, preterm, three-stair-position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three-stair-position group | Experimental | Behavioral: Three-stair-positionThe infants in the study group (n=72) received three-stair-position (TSP) intervention (head up 15°) for a week. |
| head elevated tilt position group | Other | Behavioral: Head elevated tilt position groupThe control group(n=72)received head elevated tilt position (HETP) intervention (head up 15°) for a week． |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-stair-positionInfants 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 | Behavioural | Three-stair-position group |
| Head elevated tilt position groupInfants 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. | Behavioural | head elevated tilt position group |
Primary outcome
The rate of AOP
Time frame: 7 Days
Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%
Time frame: 7 Days
9 secondary outcomes
Number of Participants who need treatments
Time frame: 7 Days
Adverse events during feeding
Time frame: 7 Days
Times of milk retention
Time frame: 7 Days
Number of Participants with distension
Time frame: 7 Days
Heart rate
Time frame: 7 Days
Number of Participants with Adverse Events
Time frame: 7 Days
amount of retention milk
Time frame: 7 Days
respiratory rate
Time frame: 7 Days
SPO2
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Three-stair-position and Head elevated tilt position group in people with Apnea of Prematurity, run by Children's Hospital of Fudan University.
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 3 inclusion and 4 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 27 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The rate of AOP (time frame: 7 Days). The study lists 2 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 27 Jan 2015.