Mothers of babies enrolled in a randomized trial immediately after birth report a positive experience.
OBJECTIVE
Randomized trials are essential for improving outcomes, but researchers can be hesitant about undertaking clinical trials in newborn babies because of perceived vulnerability of the baby and risk of increasing parental anxiety. There is a paucity of evidence about the parental experience. We investigated mothers' experiences of having their newborn baby participate in a randomized double-blind placebo-controlled trial soon after birth.


METHODS
Eligible mothers had consented to their baby's participation in the Sugar Babies Study. Mothers of potentially eligible babies were invited to join the study antenatally, but others were approached postnatally. Babies were enrolled in the study soon after birth and remained in the study for 48 h. After 2 weeks the birth mothers were interviewed by phone about their experience.


RESULTS
Four hundred and eighty-one mothers were enrolled, of whom 310 (64%) gave consent antenatally. All mothers were contacted and 477 (99%) were interviewed. The majority of mothers (458, 96%) reported they would consent to participating again, if they had another eligible baby, and 460 mothers (96%) reported they would recommend participation to family and friends. Nineteen mothers (4%) reported they did not like the heel lance blood tests, which were part of routine clinical care and not part of the trial protocol.


CONCLUSIONS
Most mothers reported the experience of having their newborn baby participate in a clinical trial as positive. Most negative responses were related to aspects of routine care rather than the trial protocol.
1] Newborn Intensive Care Unit, Waikato District Health Board, Hamilton, New Zealand [2] Liggins Institute, The University of Auckland, Auckland, New Zealand.
D L
DL
Harris
Newborn Intensive Care Unit, Waikato District Health Board, Hamilton, New Zealand.
P J
PJ
Weston
Liggins Institute, The University of Auckland, Auckland, New Zealand.
J E
JE
Harding
D000293:Adolescent; D000328:Adult; D001294:Attitude to Health; D001800:Blood Specimen Collection; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000628:therapy; D007231:Infant, Newborn; D008875:Middle Aged; D009035:Mothers / Q000523:psychology; D016032:Randomized Controlled Trials as Topic; D055815:Young Adult