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Completed

NCT Number: NCT02346864

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. The rate of AOP

    Time frame: 7 Days

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

    Time frame: 7 Days

Secondary outcomes

  1. Number of Participants who need treatments

    Time frame: 7 Days

    Treatments of AOP include stimulation, nasal cannula oxygen, pressurized oxygen, continuous positive airway pressure (CPAP), invasive mechanical ventilation, medication (pulmonary surfactant, aminophylline).

  2. Adverse events during feeding

    Time frame: 7 Days

  3. Times of milk retention

    Time frame: 7 Days

  4. Number of Participants with distension

    Time frame: 7 Days

    Distension was diagnosed by a doctor and a nurse.

  5. Heart rate

    Time frame: 7 Days

  6. Number of Participants with Adverse Events

    Time frame: 7 Days

  7. amount of retention milk

    Time frame: 7 Days

  8. respiratory rate

    Time frame: 7 Days

  9. SPO2

    Time frame: 7 Days

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2015
Registry last updated
Jan 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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