OBJECTIVE: to conduct a randomised-controlled trial to investigate the effectiveness of two heel-prick devices (Tenderfoot and Genie Lancet) used in the newborn-baby screening test. DESIGN: a randomised-controlled trial. PARTICIPANTS AND SETTING: the homes of 340 healthy term newborn babies discharged from the maternity unit of Stirling Royal Infirmary, Scotland. Data were collected between April and November 2003. INTERVENTIONS: babies were randomly allocated to be tested with either the Tenderfoot or Genie Lancet heel-prick device. MEASUREMENTS: primary study outcomes include (1) quality of the blood sample; (2) time taken to collect the sample; (3) number of heel pricks required to take the sample; (4) whether squeezing of heel was required; (5) pain expressed by the baby; and (6) presence of bruising. A potential intervening variable was the experience of the midwife. FINDINGS: on all outcomes, the Tenderfoot device was more effective than the Genie Lancet. Experienced midwives were more efficient in sample collection. KEY CONCLUSIONS: this study shows that the Tenderfoot device saves significant time for midwifery staff, improves baby care and reduces the need for more than one heel prick at each test, making it superior to the Genie Lancet device. IMPLICATIONS FOR PRACTICE: there is a case to be made for midwives to be issued with the Tenderfoot device for neonatal screening.
RCT Entities:
OBJECTIVE: to conduct a randomised-controlled trial to investigate the effectiveness of two heel-prick devices (Tenderfoot and Genie Lancet) used in the newborn-baby screening test. DESIGN: a randomised-controlled trial. PARTICIPANTS AND SETTING: the homes of 340 healthy term newborn babies discharged from the maternity unit of Stirling Royal Infirmary, Scotland. Data were collected between April and November 2003. INTERVENTIONS: babies were randomly allocated to be tested with either the Tenderfoot or Genie Lancet heel-prick device. MEASUREMENTS: primary study outcomes include (1) quality of the blood sample; (2) time taken to collect the sample; (3) number of heel pricks required to take the sample; (4) whether squeezing of heel was required; (5) pain expressed by the baby; and (6) presence of bruising. A potential intervening variable was the experience of the midwife. FINDINGS: on all outcomes, the Tenderfoot device was more effective than the Genie Lancet. Experienced midwives were more efficient in sample collection. KEY CONCLUSIONS: this study shows that the Tenderfoot device saves significant time for midwifery staff, improves baby care and reduces the need for more than one heel prick at each test, making it superior to the Genie Lancet device. IMPLICATIONS FOR PRACTICE: there is a case to be made for midwives to be issued with the Tenderfoot device for neonatal screening.