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

Effect of Three-Stair-Position on Improvement of Apnea of Prematurity and Feeding Performance in Prematurity: A Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02346864
Enrollment
144
Registered
2015-01-27
Start date
2013-12-31
Completion date
2014-12-31
Last updated
2015-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea of Prematurity

Keywords

head elevated position, preterm, three-stair-position

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.

Interventions

BEHAVIORALThree-stair-position

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

BEHAVIORALHead elevated tilt position group

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.

Sponsors

Children's Hospital of Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The rate of AOP7 Days
Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%7 Days

Secondary

MeasureTime frameDescription
Times of milk retention7 Days
Number of Participants with distension7 DaysDistension was diagnosed by a doctor and a nurse.
Heart rate7 Days
Number of Participants who need treatments7 DaysTreatments of AOP include stimulation, nasal cannula oxygen, pressurized oxygen, continuous positive airway pressure (CPAP), invasive mechanical ventilation, medication (pulmonary surfactant, aminophylline).
amount of retention milk7 Days
respiratory rate7 Days
SPO27 Days
Number of Participants with Adverse Events7 Days
Adverse events during feeding7 Days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026