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

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.

Study Overview

• Status: Completed
• Conditions: Apnea of Prematurity
• Intervention / Treatment: Behavioral: Three-stair-position; Behavioral: Head elevated tilt position group

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 Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three-stair-position group; The infants in the study group (n=72) received three-stair-position (TSP) intervention (head up 15°) for a week.	Behavioral: Three-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
Other: head elevated tilt position group; The control group(n=72)received head elevated tilt position (HETP) intervention (head up 15°) for a week．	Behavioral: Head 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 Days
Adverse events during feeding		7 Days
Times of milk retention		7 Days
Number of Participants with distension	Distension was diagnosed by a doctor and a nurse.	7 Days
Heart rate		7 Days
Number of Participants with Adverse Events		7 Days
amount of retention milk		7 Days
respiratory rate		7 Days
SPO2		7 Days

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 25, 2014
• First Submitted That Met QC Criteria: January 20, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Estimate): January 27, 2015
• Last Update Submitted That Met QC Criteria: January 20, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: preterm; head elevated position; three-stair-position
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Apnea; Premature Birth
• Other Study ID Numbers: FNF201221