Clinical trial NCT02346864: 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
Overall status: COMPLETED
Phase: NA
Conditions: Apnea of Prematurity
Keywords: head elevated position
preterm
three-stair-position
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 144
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The rate of AOP
timeFrame: 7 Days
measure: Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%
timeFrame: 7 Days
Secondary outcomes:
measure: Number of Participants who need treatments
timeFrame: 7 Days
measure: Adverse events during feeding
timeFrame: 7 Days
measure: Times of milk retention
timeFrame: 7 Days
measure: Number of Participants with distension
timeFrame: 7 Days
measure: Heart rate
timeFrame: 7 Days
measure: Number of Participants with Adverse Events
timeFrame: 7 Days
measure: amount of retention milk
timeFrame: 7 Days
measure: respiratory rate
timeFrame: 7 Days
measure: SPO2
timeFrame: 7 Days
Other outcomes:
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