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Enteral human IgG for prevention of necrotising enterocolitis: a placebo-controlled, randomised trial
G Lawrence1, D Tudehope, K Baumann
1Queensland Institute of Medical Research, PO Royal Brisbane Hospital, 4029, Brisbane, Australia. gregL@QIMR.edu.au
Insights
Enteral immunoglobulin G (IgG) supplementation does not prevent necrotising enterocolitis in premature infants. This study found no significant difference in the incidence of necrotising enterocolitis between infants receiving IgG and those receiving a placebo.
Area of Science:
- Neonatalogy
- Immunology
- Gastroenterology
Background:
- Neonatal necrotising enterocolitis (NEC) is a life-threatening condition in premature infants.
- While breast milk and good nursery practices offer some protection, effective preventive measures are still needed.
- Previous research suggested enteral immunoglobulins (IgA and IgG) might prevent NEC, but IgA is unavailable in Australia.
Purpose of the Study:
- To determine if enteral immunoglobulin G (IgG) supplementation can prevent necrotising enterocolitis in premature neonates.
Main Methods:
- A multicentre, double-blind, placebo-controlled trial involving 1529 infants.
- Infants were randomly assigned to receive either human IgG (1200 mg/kg daily) or a placebo for up to 28 days, starting with enteral feeding.
- The primary outcome was the incidence of definite necrotising enterocolitis and associated mortality.
Main Results:
- 43 infants in the IgG group developed definite necrotising enterocolitis, with 10 deaths.
- 41 infants in the placebo group developed definite necrotising enterocolitis, with 6 deaths (p=0.47).
- There was no statistically significant difference in the incidence of definite or suspect necrotising enterocolitis between the groups.
Conclusions:
- Enteral supplementation with human IgG does not reduce the incidence of necrotising enterocolitis in premature infants.
- The findings do not support the use of enteral IgG as a preventive strategy for NEC.
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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