Study to examine the effects of different styles of consent documentation on parental understanding and recruitment of babies in neonatal research

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56014081

Enrollment

Registered

2007-07-16

Start date

2001-11-30

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Neonatal research Neonatal Diseases

Interventions

Two consent forms and information sheets, used in: A. United States of America, and B. Edinburgh For the NEOPAIN Multicentre Trial will be tested. The NEOPAIN Trial was an international, randomised

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Parents of infants admitted to the Neonatal Unit within the first 72 hours of life, but not expected to require ventilation.

Exclusion criteria

Exclusion criteria: 1. Parents of infants requiring ventilation 2. Parents who are unable to read or speak English

Design outcomes

Primary

Measure	Time frame
Parental understanding of the important points of the research study.	—

Secondary

Measure	Time frame
1. Parental satisfaction with information given 2. Parental willingness to allow their baby to participate in research on the basis of the information given	—

Countries

United Kingdom

Outcome results

None listed

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