K J Barrington1, M-A Assaad1, A Janvier1. 1. Department of Pediatrics, University of Montréal Ste Justine Hospital, Centre Hospitalier Universitaire Sainte Justine, Montréal, QC, Canada.
Abstract
OBJECTIVE: To determine tolerability of bovine lactoferrin (bLF) in very preterm infants, and whether the intervention can be adequately masked. STUDY DESIGN: In a single-center masked pilot trial infants under 31 weeks gestation were randomized before 48 h of age to receive milk with 100 mg per day of bLF or control. The primary outcome was feeding tolerance, defined as time to achieve full feeds (140 ml kg(-1) per day). Parents answered a short questionnaire regarding acceptability of the intervention. RESULTS:Seventy-nine infants were enrolled and analyzed according to intention to treat. There was no effect of bLF on the primary outcome. In addition, mortality, late onset sepsis and other complications of prematurity were no different. Equal numbers of parents in both groups believed their infant received bLF. CONCLUSION: We demonstrated that bLF is well tolerated, easy to administer and its presence in prepared milk is not evident. Trial registration number ISRCTN66482337.
RCT Entities:
OBJECTIVE: To determine tolerability of bovinelactoferrin (bLF) in very preterm infants, and whether the intervention can be adequately masked. STUDY DESIGN: In a single-center masked pilot trial infants under 31 weeks gestation were randomized before 48 h of age to receive milk with 100 mg per day of bLF or control. The primary outcome was feeding tolerance, defined as time to achieve full feeds (140 ml kg(-1) per day). Parents answered a short questionnaire regarding acceptability of the intervention. RESULTS: Seventy-nine infants were enrolled and analyzed according to intention to treat. There was no effect of bLF on the primary outcome. In addition, mortality, late onset sepsis and other complications of prematurity were no different. Equal numbers of parents in both groups believed their infant received bLF. CONCLUSION: We demonstrated that bLF is well tolerated, easy to administer and its presence in prepared milk is not evident. Trial registration number ISRCTN66482337.
Authors: L Edde; R B Hipolito; F F Hwang; D R Headon; R A Shalwitz; M P Sherman Journal: Am J Physiol Gastrointest Liver Physiol Date: 2001-11 Impact factor: 4.052
Authors: Theresa J Ochoa; Jaime Zegarra; Sicilia Bellomo; Cesar P Carcamo; Luis Cam; Anne Castañeda; Aasith Villavicencio; Jorge Gonzales; Maria S Rueda; Christie G Turin; Alonso Zea-Vera; Daniel Guillen; Miguel Campos; Linda Ewing-Cobbs Journal: J Pediatr Date: 2020-02-06 Impact factor: 4.406
Authors: C G Turin; A Zea-Vera; M S Rueda; E Mercado; C P Carcamo; J Zegarra; S Bellomo; L Cam; A Castaneda; T J Ochoa Journal: J Perinatol Date: 2017-01-26 Impact factor: 2.521
Authors: Ya Gao; Liangying Hou; Cuncun Lu; Qi Wang; Bei Pan; Quan Wang; Jinhui Tian; Long Ge Journal: Front Pharmacol Date: 2020-08-07 Impact factor: 5.810