No. of Infants Included in the Study | Stopping Rule for No. of Deaths |
---|---|

1 | Continue^{a} |

2 | Continue^{a} |

3 | 3 |

4 | 3 |

5 | 4 |

6 | 4 |

7 | 4 |

8 | 5 |

9 | 5 |

10 | 5 |

11 | 5 |

12 | 6 |

13 | 6 |

14 | 6 |

↵

^{a}Based on 25% mortality in the cooled cohort, it is not unlikely that the first 2 consecutive infants might die (*P*= .06). If the third infant also dies, the probability that this is a random event is very small (*P*= .016); thus, the study should stop and review after 3 deaths.