Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05541536

Enrollment

100

Registered

2022-09-15

Start date

2022-09-01

Completion date

2023-10-05

Last updated

2023-12-15

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

Conditions

Understanding of Consent in Clinical Research, Implementation of Consent in Clinical Research

Brief summary

The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the fathers, if present) of infants eligible for trials of the Neonatal Research Network (NRN) before they are approached for consent by clinical research coordinator (CRC) approach for NRN trial). Mothers will also be given a general information pamphlet addressing the same topic.

Interventions

OTHERConsultation meeting

Study team member will approach mothers \< 24 hrs (up to 5 min prior) of CRC approach for NRN trial. During the consultation meeting (5 minutes), the study team member will review the pamphlet and answer any questions. Visits will ideally occur in person. If the mother is not at bedside, 1 attempt will be made to reach the mother by phone in which case the pamphlet will be forwarded by mail.

OTHERPamphlet

Study team member will distribute pamphlet to beside nurse to give to mother. The pamphlet provides information about Learning Health Care (LHC) and clinical research.

OTHERUsual Care

Study participants will not receive the general information pamphlet or consultation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Mothers of infants eligible for Neonatal Research Network (NRN) trial (antenatal or postnatal) * English or Spanish speaking * Available for in-person (preference) or phone consultation meeting * Mother not already approached for NRN trial

Exclusion criteria

* Mother already approached by clinical research coordinator (CRC) for NRN trial

Design outcomes

Primary

Measure	Time frame
Neonatal Research Network (NRN) trial consent rate	Within 1 week of the intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026