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

Apnea of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346864
• Other study ID #: FNF201221
• Status: Completed
• Phase: N/A
• First received: December 25, 2014
• Last updated: January 20, 2015
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Apnea
• Apnea of Prematurity
• Premature Birth

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of AOP		7 Days	No
Primary	Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%		7 Days	No
Secondary	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	No
Secondary	Adverse events during feeding		7 Days	Yes
Secondary	Times of milk retention		7 Days	No
Secondary	Number of Participants with distension	Distension was diagnosed by a doctor and a nurse.	7 Days	Yes
Secondary	Heart rate		7 Days	No
Secondary	Number of Participants with Adverse Events		7 Days	Yes
Secondary	amount of retention milk		7 Days	No
Secondary	respiratory rate		7 Days	No
Secondary	SPO2		7 Days	No