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Clinical Trials/ISRCTN10976481
ISRCTN10976481
Completed
N/A

Touch intervention might decrease the pain response during examination for retinopathy of prematurity: a blinded randomized controlled trial

anjing Medical University0 sites82 target enrollmentMarch 6, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Retinopathy of prematurity
Sponsor
anjing Medical University
Enrollment
82
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33425819/ (added 12/01/2021)

Registry
who.int
Start Date
March 6, 2020
End Date
August 30, 2019
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
anjing Medical University

Eligibility Criteria

Inclusion Criteria

  • 1\. Premature birth with a gestational age of \=34 weeks or a birth weight of \=2000 g
  • 2\. No prior history of fundus screening
  • 3\. Screening at 4 to 6 weeks of age after birth or a corrected gestational age of 31 to 32 weeks

Exclusion Criteria

  • 1\. Administration of nonsteroidal anti\-inflammatory drugs or sedative and antiepileptic drugs such as chloral hydrate, phenobarbital, and diazepam within 24 hours before ROP screening
  • 2\. Intolerance to screening because of critical conditions like severe respiratory diseases, central nervous system infections, sepsis, and other organic diseases such as severe congenital heart malformation and pulmonary insufficiency
  • 3\. Unsuitable conditions during ROP screening, such as severe coughing and shortness of breath

Outcomes

Primary Outcomes

Not specified

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