Bovine colostrum to supplement the first feeding of very preterm infants: The PreColos randomized controlled trial
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Bovine colostrum to supplement the first feeding of very preterm infants : The PreColos randomized controlled trial. / Yan, Xudong; Pan, Xiaoyu; Ding, Lu; Dai, Yiheng; Chen, Jun; Yang, Yong; Li, Yuefeng; Hao, Hu; Qiu, Huixian; Ye, Zhenzhi; Shen, René Liang; Li, Yanqi; Ritz, Christian; Peng, Yueming; Zhou, Ping; Gao, Fei; Jiang, Ping Ping; Lin, Hung Chih; Zachariassen, Gitte; Sangild, Per Torp; Wu, Benqing.
I: Clinical Nutrition, Bind 42, Nr. 8, 2023, s. 1408-1417.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Bovine colostrum to supplement the first feeding of very preterm infants
T2 - The PreColos randomized controlled trial
AU - Yan, Xudong
AU - Pan, Xiaoyu
AU - Ding, Lu
AU - Dai, Yiheng
AU - Chen, Jun
AU - Yang, Yong
AU - Li, Yuefeng
AU - Hao, Hu
AU - Qiu, Huixian
AU - Ye, Zhenzhi
AU - Shen, René Liang
AU - Li, Yanqi
AU - Ritz, Christian
AU - Peng, Yueming
AU - Zhou, Ping
AU - Gao, Fei
AU - Jiang, Ping Ping
AU - Lin, Hung Chih
AU - Zachariassen, Gitte
AU - Sangild, Per Torp
AU - Wu, Benqing
N1 - Publisher Copyright: © 2023 The Author(s)
PY - 2023
Y1 - 2023
N2 - Background & aims: Gut immaturity leads to feeding difficulties in very preterm infants (<32 weeks gestation at birth). Maternal milk (MM) is the optimal diet but often absent or insufficient. We hypothesized that bovine colostrum (BC), rich in protein and bioactive components, improves enteral feeding progression, relative to preterm formula (PF), when supplemented to MM. Aim of the study is to determine whether BC supplementation to MM during the first 14 days of life shortens the time to full enteral feeding (120 mL/kg/d, TFF120). Methods: This was a multicenter, randomized, controlled trial at seven hospitals in South China without access to human donor milk and with slow feeding progression. Infants were randomly assigned to receive BC or PF when MM was insufficient. Volume of BC was restricted by recommended protein intake (4–4.5 g/kg/d). Primary outcome was TFF120. Feeding intolerance, growth, morbidities and blood parameters were recorded to assess safety. Results: A total of 350 infants were recruited. BC supplementation had no effect on TFF120 in intention-to-treat analysis [n (BC) = 171, n (PF) = 179; adjusted hazard ratio, aHR: 0.82 (95% CI: 0.64, 1.06); P = 0.13]. Body growth and morbidities did not differ, but more cases of periventricular leukomalacia were detected in the infants fed BC (5/155 vs. 0/181, P = 0.06). Blood chemistry and hematology data were similar between the intervention groups. Conclusions: BC supplementation during the first two weeks of life did not reduce TFF120 and had only marginal effects on clinical variables. Clinical effects of BC supplementation on very preterm infants in the first weeks of life may depend on feeding regimen and remaining milk diet. Trial Registration: http://www.clinicaltrials.gov: NCT03085277.
AB - Background & aims: Gut immaturity leads to feeding difficulties in very preterm infants (<32 weeks gestation at birth). Maternal milk (MM) is the optimal diet but often absent or insufficient. We hypothesized that bovine colostrum (BC), rich in protein and bioactive components, improves enteral feeding progression, relative to preterm formula (PF), when supplemented to MM. Aim of the study is to determine whether BC supplementation to MM during the first 14 days of life shortens the time to full enteral feeding (120 mL/kg/d, TFF120). Methods: This was a multicenter, randomized, controlled trial at seven hospitals in South China without access to human donor milk and with slow feeding progression. Infants were randomly assigned to receive BC or PF when MM was insufficient. Volume of BC was restricted by recommended protein intake (4–4.5 g/kg/d). Primary outcome was TFF120. Feeding intolerance, growth, morbidities and blood parameters were recorded to assess safety. Results: A total of 350 infants were recruited. BC supplementation had no effect on TFF120 in intention-to-treat analysis [n (BC) = 171, n (PF) = 179; adjusted hazard ratio, aHR: 0.82 (95% CI: 0.64, 1.06); P = 0.13]. Body growth and morbidities did not differ, but more cases of periventricular leukomalacia were detected in the infants fed BC (5/155 vs. 0/181, P = 0.06). Blood chemistry and hematology data were similar between the intervention groups. Conclusions: BC supplementation during the first two weeks of life did not reduce TFF120 and had only marginal effects on clinical variables. Clinical effects of BC supplementation on very preterm infants in the first weeks of life may depend on feeding regimen and remaining milk diet. Trial Registration: http://www.clinicaltrials.gov: NCT03085277.
KW - Bovine colostrum
KW - Early enteral feeding
KW - Maternal milk
KW - Preterm infant
KW - Time to full enteral feeding
U2 - 10.1016/j.clnu.2023.06.024
DO - 10.1016/j.clnu.2023.06.024
M3 - Journal article
C2 - 37437359
AN - SCOPUS:85164308902
VL - 42
SP - 1408
EP - 1417
JO - Clinical Nutrition
JF - Clinical Nutrition
SN - 0261-5614
IS - 8
ER -
ID: 362697682