Bibliographic Details
| Title: |
Isoniazid preventive therapy during infancy does not adversely affect growth among HIV-exposed uninfected children: Secondary analysis of data from a randomized controlled trial. |
| Authors: |
Cherkos, Ashenafi Shumey1 (AUTHOR), LaCourse, Sylvia M.2,3,4 (AUTHOR), Enquobahrie, Daniel A.2 (AUTHOR), Escudero, Jaclyn N.4 (AUTHOR), Mecha, Jerphason5 (AUTHOR), Matemo, Daniel6 (AUTHOR), Kinuthia, John6,7 (AUTHOR), Iribarren, Sarah J.8 (AUTHOR), John-Stewart, Grace2,3,4,9 (AUTHOR) gjohn@uw.edu |
| Source: |
PLoS ONE. 8/16/2024, Vol. 19 Issue 8, p1-13. 13p. |
| Subject Terms: |
*INFECTION prevention, *RANDOMIZED controlled trials, *ISONIAZID, *INFANTS, *LINEAR statistical models |
| Abstract: |
Background: Isoniazid preventive therapy (IPT) decreases risk of tuberculosis (TB) disease; impact on long-term infant growth is unknown. In a recent randomized trial (RCT), we assessed IPT effects on infant growth without known TB exposure. Methods: The infant TB Infection Prevention Study (iTIPS) trial was a non-blinded RCT among HIV-exposed uninfected (HEU) infants in Kenya. Inclusion criteria included age 6–10 weeks, birthweight ≥2.5 kg, and gestation ≥37 weeks. Infants in the IPT arm received 10 mg/kg isoniazid daily for 12 months, while the control trial received no intervention; post-trial observational follow-up continued through 24 months of age. We used intent-to-treat linear mixed-effects models to compare growth rates (weight-for-age z-score [WAZ] and height-for-age z-score [HAZ]) between trial arms. Results: Among 298 infants, 150 were randomized to IPT, 47.6% were females, median birthweight was 3.4 kg (interquartile range [IQR] 3.0–3.7), and 98.3% were breastfed. During the 12-month intervention period and 12-month post-RCT follow-up, WAZ and HAZ declined significantly in all children, with more HAZ decline in male infants. There were no growth differences between trial arms, including in sex-stratified analyses. In longitudinal linear analysis, mean WAZ (β = 0.04 [95% CI:-0.14, 0.22]), HAZ (β = 0.14 [95% CI:-0.06, 0.34]), and WHZ [β = -0.07 [95% CI:-0.26, 0.11]) z-scores were similar between arms as were WAZ and HAZ growth trajectories. Infants randomized to IPT had higher monthly WHZ increase (β to 24 months 0.02 [95% CI:0.01, 0.04]) than the no-IPT arm. Conclusion: IPT administered to HEU infants did not significantly impact growth outcomes in the first two years of life. [ABSTRACT FROM AUTHOR] |
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