The value of a pilot study in breast-feeding research.
OBJECTIVE
To test the integrity of a protocol for a randomised controlled trial (RCT) to examine the effectiveness of skin-to-skin care compared to routine care on the initiation and duration of breast feeding and to provide data to be used in the power calculation for a proposed trial.


METHODS
Randomised pilot study.


METHODS
Warrington Hospital, Cheshire, UK.


METHODS
Women at 36 weeks' gestation with healthy singleton pregnancies, who intended to breast feed, who had 'booked' for care at Warrington Hospital and had given informed consent to participate. Twenty-eight women were randomised in the pilot study.


METHODS
Women were randomly allocated to receive either routine or skin-to-skin care following birth. The first breast feed was assessed using the Breast-feeding Assessment Tool (BAT). Mothers were followed up at discharge from hospital and again at four months to provide details of duration of breast feeding.


RESULTS
66 women were approached to participate in the trial and 44 consented (67% consent rate). Twenty-eight women were randomised in the study and 26 breast feeds were observed (93%). The pilot study identified procedural changes that were required in the design of the main study, provided an estimate of recruitment rates and confirmed the previously calculated sample size.


CONCLUSIONS
The pilot study demonstrated that a large RCT of skin-to-skin versus routine care was feasible. This is an example of how a pilot study has the ability to identify unforeseen challenges in the conduct of the trial as well as allowing necessary changes to be made to the design that will increase the quality of the subsequent research.
Carfoot
Sue
S
Women's Health Directorate, Croft Wing, North Cheshire Hospitals NHS Trust, Lovely Lane, Warrington, Cheshire WA1 5QG, UK. suecarfoot@blueyonder.co.uk
Williamson
Paula R
PR
Dickson
Rumona
R
D000328:Adult; D001942:Breast Feeding / Q000523:psychology / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D009034:Mother-Child Relations; D009035:Mothers / Q000193:education / Q000523:psychology; D015403:Nursing Evaluation Research; D010043:Outcome and Process Assessment, Health Care; D010865:Pilot Projects; D011181:Postnatal Care / Q000379:methods; D011247:Pregnancy; D012107:Research Design / Q000592:standards*; D014110:Touch; D006113:United Kingdom