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The influence of different prone position strategies under nasal continuous positive airway pressure ventilation on neonates with respiratory distress syndrome

The influence of different prone position strategies under nasal continuous positive airway pressure ventilation on neonates with respiratory distress syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111013
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatal respiratory distress syndrome

Interventions

Control group:Adopt the standard supine position: The abdomen of the newborn is in contact with the bed. Use a protractor to measure that the head of the bed is raised by 15°, the head is tilted to on
Test group A:Use the prone position support pad in the neonatal care equipment: Use a protractor to measure that the head of the bed should be raised by 15 degrees. Place the infant in a prone positio
Test group B:Implementing the three-level supine position intervention: (1) Prepare the three-level supine position cotton pads: Take a soft towel, first fold the first-level cotton pad to a height of

Sponsors

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Newborns who had their umbilical cord tied at birth and were within 28 days of age, meeting the diagnostic criteria for respiratory distress syndrome, regardless of gender; (2) Require non-invasive ventilator-assisted breathing (nasal continuous positive airway pressure ventilation); (3) The parents of the children have given informed consent and signed the document.

Exclusion criteria

Exclusion criteria: (1) History of neonatal asphyxia at birth: 1) There were high-risk factors that could lead to asphyxia before birth; 2) 1 or 5-minute Apgar score <= 7, and no effective spontaneous breathing had been established; 3) Umbilical artery blood pH < 7.15; 4) Other causes causing low Apgar score were excluded. The above 2) - 4) are necessary conditions, and 1) is a reference condition; (2) Respiratory failure caused by other related diseases except the respiratory system (central respiratory failure, cardiogenic respiratory failure, etc.), thoracic deformity, respiratory muscle paralysis, etc.; (3) Head B-ultrasound or cranial MRI examination indicates evidence of intracranial hemorrhage, cerebral infarction, periventricular leukomalacia or brain malformations; (4) Neonates with persistent hypoglycemia or neonates with hyperglycemia who received insulin intervention; (5) Those who cannot tolerate changes in body position: persistent hypotension, trauma, fracture, or unstable hemodynamics when in the prone position.

Design outcomes

Primary

MeasureTime frame
Number of days of non-invasive respiratory support;

Secondary

MeasureTime frame
The number of days receiving oxygen therapy in the hospital;transcutaneous oxygen saturation;respiratory rate;The incidence of apnea;The incidence of pneumothorax;heart rate;blood pressure;The incidence of abdominal distension;The incidence of vomiting;Duration of gastric tube insertion;The time for achieving full enteral feeding;Number of severe complications;Incidence of pressure injuries;The incidence of nasal catheter detachment;The incidence of gastric tube detachment;length of stay;Rate of weight gain;

Countries

China

Contacts

Public ContactLi Run

Affiliated Hospital of Traditional Chinese Medicine of Southwest Medical University

843485744@qq.com+86 135 5166 8989

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026