Abstract
OBJECTIVE: We performed a randomised trial in very preterm, small for gestational age (SGA) babies to determine if prophylaxis with granulocyte macrophage colony stimulating factor (GM-CSF) improves outcomes (the PROGRAMS trial). GM-CSF was associated with improved neonatal neutrophil counts, but no change in other neonatal or 2-year outcomes. As subtle benefits in outcome may not be ascertainable until school age we performed an outcome study at 5 years.
PATIENTS AND METHODS: 280 babies born at 31 weeks of gestation or less and SGA were entered into the trial. Outcomes were assessed at 5 years to determine neurodevelopmental and general health status and educational attainment.
RESULTS: We found no significant differences in cognitive, general health or educational outcomes between 83 of 106 (78%) surviving children in the GM-CSF arm compared with 81 of 110 (74%) in the control arm. Mean mental processing composite (equivalent to IQ) at 5 years were 94 (SD 16) compared with 95 (SD 15), respectively (difference in means -1 (95%CI -6 to 4), and similar proportions were in receipt of special educational needs support (41% vs 35%; risk ratio 1.2 (95% CI 0.8 to 1.9)). Performance on Kaufmann-ABC subscales and components of NEPSY were similar. The suggestion of worse respiratory outcomes in the GM-CSF group at 2 years was replicated at 5 years.
CONCLUSIONS: The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse neurodevelopmental, general health or educational outcomes at 5 years.
TRIAL REGISTRATION NUMBER: ISRCTN42553489.
Original language | English |
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Pages (from-to) | F320-F326 |
Number of pages | 7 |
Journal | Archives of disease in childhood. Fetal and neonatal edition |
Volume | 100 |
Early online date | 28 Apr 2015 |
DOIs | |
Publication status | Published - Jul 2015 |
Keywords
- Child Development
- Female
- Granulocyte-Macrophage Colony-Stimulating Factor
- Hematologic Agents
- Humans
- Infant, Extremely Premature
- Infant, Newborn
- Infant, Small for Gestational Age
- Leukocyte Count
- Male
- Neuropsychological Tests
- Neutrophils
- Outcome Assessment (Health Care)
- Sepsis
- Time
- Journal Article
- Randomized Controlled Trial
- Research Support, Non-U.S. Gov't