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Oral immunoglobulin for preventing necrotizing enterocolitis in preterm and low birth weight neonates

  • Review
  • Intervention




Necrotizing enterocolitis (NEC) is the most common emergency involving the gastrointestinal tract occurring in the neonatal period. There have been published reports that suggest that oral immunoglobulins IgA and IgG produce an immunoprotective effect in the gastrointestinal mucosa.


To determine the effect of oral immunoglobulin on the incidence of necrotizing enterocolitis and other complications in preterm and/or low birth weight neonates.

Search methods

We used the standard search strategy of the Cochrane Neonatal Group. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library 2011, Issue 3), MEDLINE (1966 to March 26, 2011), CINAHL (1982 to March 26, 2011) and EMBASE (1980 to March 26, 2011) and conference proceedings.

Selection criteria

All randomised or quasi-randomised controlled trials where oral immunoglobulins were used as prophylaxis against necrotizing enterocolitis in preterm (< 37 weeks gestation) and/or low birth weight (< 2500 g) neonates.

Data collection and analysis

Data collection and analysis was performed in accordance with the standard methods of the Cochrane Neonatal Review Group.

Main results

Five studies on oral immunoglobulin for the prevention of necrotizing enterocolitis were identified of which three met the inclusion criteria. In this review of the three eligible trials (including a total of 2095 neonates), the oral administration of IgG or an IgG/IgA combination did not result in a significant reduction in the incidence of definite NEC [typical RR 0.84 (95% CI 0.57 to 1.25), typical RD -0.01 (95% CI -0.03 to 0.01)], suspected NEC [RR 0.84 (95% CI 0.49 to 1.46), RD -0.01 (95% CI -0.02 to 0.01)], need for surgery [typical RR 0.21 (95% CI 0.02 to 1.75), typical RD -0.03 (95% CI -0.06 to 0.00)] or death from NEC [typical RR 1.10 (95% CI 0.47 to 2.59), typical RD 0.00 (95% CI -0.01 to 0.01)].

Authors' conclusions

Based on the available trials, the evidence does not support the administration of oral immunoglobulin for the prevention of NEC. There are no randomised controlled trials of oral IgA alone for the prevention of NEC.

Plain language summary

Oral immunoglobulin for preventing necrotizing enterocolitis in preterm and low birth weight neonates

Immunoglobulin given orally for preventing emergency intestinal problems (necrotizing enterocolitis) in premature and low birth weight newborn infants. Destructive inflammation of the intestine (necrotizing enterocolitis, NEC) is caused by gas-producing bacteria that ferment milk. It is a potential problem for newborn preterm and low birth weight (less than 2500 grams) infants. Even after leaving hospital, affected infants may need frequent and prolonged hospitalisation because of continuing nutritional problems. This makes it difficult for parents both emotionally and financially. Immunoglobulins are proteins found in the blood that give the body immunity to disease. Immunoglobulins (types IgA and IgG) taken orally may protect susceptible infants from developing necrotizing enterocolitis. The review authors searched the medical literature and found three randomised controlled trials (with 2095 newborn infants). Treatment was started either in the first twenty-four hours following birth (two small studies) or following commencement of oral feeding (enteral) (one large well-controlled study). In this large study, infants generally received breast milk, whereas they received formula milk in the other two studies. Giving immunoglobulin (IgG or an IgG and IgA combination) did not reduce the incidence of NEC, need for surgery related to NEC, or death from NEC, either during or after the study period. Immunoglobulins could possibly cause breakdown of red blood cells (haemolysis), but no clinically important haemolysis was apparent. There were no other reported side effects.