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

NCT02346864 | Completed DMC

• 1 other identifier: FNF201221
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Apnea of Prematurity

Keywords

head elevated position; preterm; three-stair-position

Outcome Measures

Primary Outcomes (2)

• The rate of AOP

  7 Days

• Frequency of desaturation which defined as oxygen saturation by pulse oximetry (SPO2)<85%

  7 Days

Secondary Outcomes (9)

• Number of Participants who need treatments

  7 Days

• Adverse events during feeding

  7 Days

• Times of milk retention

  7 Days

• Number of Participants with distension

  7 Days

• Heart rate

  7 Days

Study Arms (2)

Three-stair-position group

EXPERIMENTAL

The infants in the study group (n=72) received three-stair-position (TSP) intervention (head up 15°) for a week.

Behavioral: Three-stair-position

head elevated tilt position group

OTHER

The control group(n=72)received head elevated tilt position (HETP) intervention (head up 15°) for a week．

Behavioral: Head elevated tilt position group

Interventions

Three-stair-position BEHAVIORAL

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

Three-stair-position group

Head elevated tilt position group BEHAVIORAL

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.

head elevated tilt position group

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm, gestational age(GA) \<34weeks determined by obstetric ultra-sonogram and clinical examination
• steady vital signs
• Apgar scores were greater than or equal to 3 at 1min and greater than or equal to 5 at 5 minutes.

You may not qualify if:

• infants with congenital malformation，for example Congenital Heart Disease, Diaphragmatic hernia, Hirschsprung,etc
• Infants who need special position and/or intervention (gastroschisis or umbilical catheterization)
• weight\<1000g
• infants who were undertaking conventional invasive mechanical ventilation.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

MeSH Terms

Conditions

Apnea; Premature Birth

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2014
• First Posted: January 27, 2015
• Study Start: December 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 27, 2015

Record last verified: 2015-01