Baby PANDA Study

Design:

Prospective observational cohort study aligned with the Giant PANDA study.

Objectives:

1) To determine short-term BP response of nifedipine versus labetalol.

2) To explore the association between short-term BP response and long-term BP control (Giant PANDA primary outcome).

3) To assess whether maternal characteristics, disease markers or drug metabolites provide mechanistic insight into differing responses to antihypertensive agents between individuals.

Principle Outcome: 8 hour systolic BP post-dose response to labetalol or nifedipine.

Secondary outcomes: Short-term BP response, including 8-hour diastolic BP post-dose response to labetalol or nifedipine (proportion of systolic BP readings ≥140mmHg), 8 hour post dose proportion of BP readings ≥ 140mmHg systolic or ≥ 90mmHg diastolic readings, BP variability, 24 hour post-dose BP parameters, medication adherence and renin and aldosterone concentrations.

Baby PANDA Trial Protocol version 1.1

Baby PANDA trial information sheet and consent form version 1.1

This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and sponsored by the University of Birmingham. The Chief Investigator, Professor Lucy Chappell, is based at King’s College London and she is running the study with the Birmingham Clinical Trials Unit.