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Mothers of babies enrolled in a randomized trial immediately after birth report a positive experience

Journal of Perinatology volume 34, pages 280–283 (2014)Cite this article

Subjects

Abstract

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.

Study Design:

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.

Result:

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.

Conclusion:

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.

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Acknowledgements

We thank all the families enrolled in the Sugar Babies Study and the staff at Waikato Women's Hospital, particularly research nurses Catherine McBride and Paula Middlemiss. The Sugar Babies Study was funded from the Waikato Medical Research Foundation, the Auckland Medical Research Foundation, the Maurice and Phyllis Paykel Trust, the Health Research Council of New Zealand and the Rebecca Roberts Scholarship.

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Authors and Affiliations

  1. Newborn Intensive Care Unit, Waikato District Health Board, Hamilton, New Zealand

    D L Harris & P J Weston

  2. Liggins Institute, The University of Auckland, Auckland, New Zealand

    D L Harris & J E Harding

Authors
  1. D L Harris
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  2. P J Weston
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  3. J E Harding
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Corresponding author

Correspondence to J E Harding.

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The authors declare no conflict of interest.

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Harris, D., Weston, P. & Harding, J. Mothers of babies enrolled in a randomized trial immediately after birth report a positive experience. J Perinatol 34, 280–283 (2014). https://doi.org/10.1038/jp.2013.183

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