Enteral human IgG for prevention of necrotising enterocolitis: A placebo-controlled, randomised trial

Gregor Lawrence, David Tudehope, Kathryn Baumann, Heather Jeffery, Andrew Gill, Michael Cole, John Drew, Andrew McPhee, John Ratcliffe, Graham Reynolds, John Simes, Cheryl Swanson, David Cartwright, Peter Davis, Ian Humphrey, Andrew Berry

Research output: Contribution to journalArticle

19 Citations (Scopus)

Abstract

Background: Neonatal necrotising enterocolitis is a serious, commonly fatal disease in premature neonates. Although feeding with expressed breast milk and other good nursery practices are partly protective, preventive measures are needed. Treating neonates enterally with a mixture of human IgA and IgG, prepared from donated blood, has been claimed to protect against necrotising enterocolitis. However, no IgA preparation is available in Australia. Our aim, therefore, was to identify whether or not enteral IgG could prevent the disorder. Methods: We did a multicentre, double-blind, placebo-controlled trial. We randomly assigned 768 infants to receive human IgG 1200 mg/kg daily, and 761 to receive placebo, for up to 28 days. Treatment began at the same time as enteral feeding. The primary outcome measure was the proportion of infants who developed definite necrotising enterocolitis during the trial, and any deaths that resulted from the disorder in the treatment and placebo groups. Analysis was on an intention-to-treat basis. Findings: 43 infants developed definite necrotising enterocolitis in the IgG group, ten of whom died. In the placebo group, 41 infants contracted the disorder and six died (p=0·47). 25 infants on IgG and 36 on placebo had suspect necrotising enterocolitis (p=0·14). Interpretation: Supplementation of enteral feeds with human IgG does not reduce necrotising enterocolitis.

LanguageEnglish
Pages2090-2094
Number of pages5
JournalLancet
Volume357
Issue number9274
DOIs
Publication statusPublished - 30 Jun 2001
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Lawrence, G., Tudehope, D., Baumann, K., Jeffery, H., Gill, A., Cole, M., ... Berry, A. (2001). Enteral human IgG for prevention of necrotising enterocolitis: A placebo-controlled, randomised trial. Lancet, 357(9274), 2090-2094. https://doi.org/10.1016/S0140-6736(00)05182-5
Lawrence, Gregor ; Tudehope, David ; Baumann, Kathryn ; Jeffery, Heather ; Gill, Andrew ; Cole, Michael ; Drew, John ; McPhee, Andrew ; Ratcliffe, John ; Reynolds, Graham ; Simes, John ; Swanson, Cheryl ; Cartwright, David ; Davis, Peter ; Humphrey, Ian ; Berry, Andrew. / Enteral human IgG for prevention of necrotising enterocolitis : A placebo-controlled, randomised trial. In: Lancet. 2001 ; Vol. 357, No. 9274. pp. 2090-2094.
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Lawrence, G, Tudehope, D, Baumann, K, Jeffery, H, Gill, A, Cole, M, Drew, J, McPhee, A, Ratcliffe, J, Reynolds, G, Simes, J, Swanson, C, Cartwright, D, Davis, P, Humphrey, I & Berry, A 2001, 'Enteral human IgG for prevention of necrotising enterocolitis: A placebo-controlled, randomised trial', Lancet, vol. 357, no. 9274, pp. 2090-2094. https://doi.org/10.1016/S0140-6736(00)05182-5

Enteral human IgG for prevention of necrotising enterocolitis : A placebo-controlled, randomised trial. / Lawrence, Gregor; Tudehope, David; Baumann, Kathryn; Jeffery, Heather; Gill, Andrew; Cole, Michael; Drew, John; McPhee, Andrew; Ratcliffe, John; Reynolds, Graham; Simes, John; Swanson, Cheryl; Cartwright, David; Davis, Peter; Humphrey, Ian; Berry, Andrew.

In: Lancet, Vol. 357, No. 9274, 30.06.2001, p. 2090-2094.

Research output: Contribution to journalArticle

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T1 - Enteral human IgG for prevention of necrotising enterocolitis

T2 - Lancet

AU - Lawrence, Gregor

AU - Tudehope, David

AU - Baumann, Kathryn

AU - Jeffery, Heather

AU - Gill, Andrew

AU - Cole, Michael

AU - Drew, John

AU - McPhee, Andrew

AU - Ratcliffe, John

AU - Reynolds, Graham

AU - Simes, John

AU - Swanson, Cheryl

AU - Cartwright, David

AU - Davis, Peter

AU - Humphrey, Ian

AU - Berry, Andrew

PY - 2001/6/30

Y1 - 2001/6/30

N2 - Background: Neonatal necrotising enterocolitis is a serious, commonly fatal disease in premature neonates. Although feeding with expressed breast milk and other good nursery practices are partly protective, preventive measures are needed. Treating neonates enterally with a mixture of human IgA and IgG, prepared from donated blood, has been claimed to protect against necrotising enterocolitis. However, no IgA preparation is available in Australia. Our aim, therefore, was to identify whether or not enteral IgG could prevent the disorder. Methods: We did a multicentre, double-blind, placebo-controlled trial. We randomly assigned 768 infants to receive human IgG 1200 mg/kg daily, and 761 to receive placebo, for up to 28 days. Treatment began at the same time as enteral feeding. The primary outcome measure was the proportion of infants who developed definite necrotising enterocolitis during the trial, and any deaths that resulted from the disorder in the treatment and placebo groups. Analysis was on an intention-to-treat basis. Findings: 43 infants developed definite necrotising enterocolitis in the IgG group, ten of whom died. In the placebo group, 41 infants contracted the disorder and six died (p=0·47). 25 infants on IgG and 36 on placebo had suspect necrotising enterocolitis (p=0·14). Interpretation: Supplementation of enteral feeds with human IgG does not reduce necrotising enterocolitis.

AB - Background: Neonatal necrotising enterocolitis is a serious, commonly fatal disease in premature neonates. Although feeding with expressed breast milk and other good nursery practices are partly protective, preventive measures are needed. Treating neonates enterally with a mixture of human IgA and IgG, prepared from donated blood, has been claimed to protect against necrotising enterocolitis. However, no IgA preparation is available in Australia. Our aim, therefore, was to identify whether or not enteral IgG could prevent the disorder. Methods: We did a multicentre, double-blind, placebo-controlled trial. We randomly assigned 768 infants to receive human IgG 1200 mg/kg daily, and 761 to receive placebo, for up to 28 days. Treatment began at the same time as enteral feeding. The primary outcome measure was the proportion of infants who developed definite necrotising enterocolitis during the trial, and any deaths that resulted from the disorder in the treatment and placebo groups. Analysis was on an intention-to-treat basis. Findings: 43 infants developed definite necrotising enterocolitis in the IgG group, ten of whom died. In the placebo group, 41 infants contracted the disorder and six died (p=0·47). 25 infants on IgG and 36 on placebo had suspect necrotising enterocolitis (p=0·14). Interpretation: Supplementation of enteral feeds with human IgG does not reduce necrotising enterocolitis.

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JF - Lancet

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Lawrence G, Tudehope D, Baumann K, Jeffery H, Gill A, Cole M et al. Enteral human IgG for prevention of necrotising enterocolitis: A placebo-controlled, randomised trial. Lancet. 2001 Jun 30;357(9274):2090-2094. https://doi.org/10.1016/S0140-6736(00)05182-5