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

Not Applicable

Completed

• Conditions: Apnea of Prematurity
• Interventions: Behavioral: Three-stair-position; Behavioral: Head elevated tilt position group

• Registration Number: NCT02346864
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Study First Submitted: 2014-12-25
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-20
• Last Update Submitted: 2015-01-20
• Study First Posted: 2015-01-27
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three-stair-position group	Three-stair-position	The infants in the study group (n=72) received three-stair-position (TSP) intervention (head up 15°) for a week.
head elevated tilt position group	Head elevated tilt position group	The control group(n=72)received head elevated tilt position (HETP) intervention (head up 15°) for a week．

Primary Outcome Measures

Name	Time	Method
Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%	7 Days
The rate of AOP	7 Days

Secondary Outcome Measures

Name	Time	Method
Adverse events during feeding	7 Days
respiratory rate	7 Days
Number of Participants with distension	7 Days	Distension was diagnosed by a doctor and a nurse.
amount of retention milk	7 Days
SPO2	7 Days
Times of milk retention	7 Days
Heart rate	7 Days
Number of Participants with Adverse Events	7 Days
Number of Participants who need treatments	7 Days	Treatments of AOP include stimulation, nasal cannula oxygen, pressurized oxygen, continuous positive airway pressure (CPAP), invasive mechanical ventilation, medication (pulmonary surfactant, aminophylline).