- Histamine-2 receptor antagonists (H2RAs) reduce risk for gastrointestinal (GI) bleeding in high-risk newborns, but evidence that H2RAs and proton pump inhibitors (PPIs) decrease duration or continuation of existing bleeding is very low quality.
Why this matters
- Findings suggest the need for caution in using H2RAs or PPIs in this population.
- With H2RAs (4 trials), upper GI bleeding risk was reduced in high-risk infants:
- Typical risk ratio, 0.36 (95% CI, 0.22-0.58),
- Typical risk difference: −0.20 (95% CI, −0.28 to −0.11),
- Number needed to treat for beneficial outcome: 5 (95% CI, 4-9), and
- Moderate quality of evidence.
- In 1 small trial (n=53) of H2RAs vs no intervention, no mortality effect was identified, with very low-quality evidence.
- In infants with existing bleeding, H2RAs or PPIs reduced duration or continuation, but evidence quality was very low and low, respectively.
- 1 small trial found no difference in need for transfusion with H2RAs vs no treatment.
- Major morbidities, duration of hospital stay, long-term outcomes were not reported.
- No trial had a low bias risk.
- Cochrane review of 11 randomized trials (818 infants).
- Funding: Vermont Oxford Network, USA; National Institute for Health Research, UK.
- Mostly low, very low quality of evidence.