Mortality, Morbidity, and Developmental Outcomes in Infants Born to Women Who Received Either Mefloquine or Sulfadoxine-Pyrimethamine as Intermittent Preventive Treatment of Malaria in Pregnancy: A Cohort Study

1. Steketee RW, Nahlen BL, Parise ME, Menendez C. The burden of malaria in pregnancy in malaria-endemic areas. Am J Trop Med Hyg. 2001;64(1–2 Suppl):28–35. 11425175

2. Bardaji A, Sigauque B, Sanz S, Maixenchs M, Ordi J, Aponte JJ, et al. Impact of malaria at the end of pregnancy on infant mortality and morbidity. J Infect Dis. 2011;203:691–699. doi: 10.1093/infdis/jiq049 21199881

3. Nyirjesy P, Kavasya T, Axelrod P, Fischer PR. Malaria during pregnancy: neonatalmorbidity and mortality and the efficacy of chloroquine chemoprophylaxis. Clin Infect Dis. 1993;16:127–132. 8448288

4. Bloland PB, Wirima JJ, Steketee RW, Chilima B, Hightower A, Breman JG. Maternal HIV infection and infant mortality in Malawi: evidence for increased mortality due to placental malaria infection. AIDS. 1995;9:721–726. 7546417

5. Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, Brabin B, et al. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis. 2007;7:93–104. 17251080

6. Greenwood BM, Greenwood AM, Snow RW, Byass P, Bennett S, Hatib-N’Jie AB. The effects of malaria chemoprophylaxis given by traditional birth attendants on the course and outcome of pregnancy. Trans R Soc Trop Med Hyg. 1989;83:589–594. 2617619

7. Guyatt HL, Snow RW. Impact of malaria during pregnancy on low birth weight in sub- Saharan Africa. Clin Microbiol Rev. 2004;17:760–769. 15489346

8. Le Hesran JY, Fievet N, Thioulouse J, Personne P, Maubert B, M’Bidias S, et al. Development of cellular immune responses to Plasmodium falciparum blood stage antigens from birth to 36 months of age in Cameroon. Acta Trop. 2006;98:261–269. 16820138

9. Menendez C, D’Alessandro U, ter Kuile FO. Reducing the burden of malaria in pregnancy by preventive strategies. Lancet Infect Dis. 2007;7:126–135. 17251083

10. Menendez C, Mayor A. Congenital malaria: the least known consequence of malaria in pregnancy. Semin Fetal Neonatal Med. 2007;12:207–213. 17483042

11. Menendez C, Ordi J, Ismail MR, Ventura PJ, Aponte JJ, Kahigwa E, et al. The impact of placental malaria on gestational age and birth weight. J Infect Dis. 2000;181:1740–1745. 10823776

12. Schwarz NG, Adegnika AA, Breitling LP, Gabor J, Agnandji ST, Newman RD, et al. Placental malaria increases malaria risk in the first 30 months of life. Clin Infect Dis. 2008;47:1017–1025. doi: 10.1086/591968 18781874

13. Shulman CE, Dorman EK, Bulmer JN. Malaria as a cause of severe anaemia in pregnancy. Lancet. 2002;360:494.

14. Steketee RW, Wirima JJ, Hightower AW, Slutsker L, Heymann DL, Breman JG. The effect of malaria and malaria prevention in pregnancy on offspring birthweight, prematurity, and intrauterine growth retardation in rural Malawi. Am J Trop Med Hyg. 1996;55(1 Suppl): 33–41. 8702035

15. van Geertruyden JP, Thomas F, Erhart A, D’Alessandro U. The contribution of malaria inpregnancy to perinatal mortality. Am J Trop Med Hyg. 2004;71(2 Suppl): 35–40. 15331817

16. World Health Organization. A strategic framework for malaria prevention and control during pregnancy in the African region. Geneva: World Health Organization; 2004.

17. Menendez C, Bardaji A, Sigauque B, Romagosa C, Sanz S, Serra-Casas E, et al. A randomized placebo-controlled trial of intermittent preventive treatment in pregnant women in the context of insecticide treated nets delivered through the antenatal clinic. PLoS ONE. 2008;3:e1934. doi: 10.1371/journal.pone.0001934 18398460

18. Menendez C, Bardaji A, Sigauque B, Sanz S, Aponte JJ, Mabunda S, et al. Malaria prevention with IPTp during pregnancy reduces neonatal mortality. PLoS ONE. 2010;5:e9438. doi: 10.1371/journal.pone.0009438 20195472

19. Ramharter M, Wernsdorfer WH, Kremsner PG. In vitro activity of quinolines against Plasmodium falciparum in Gabon. Acta Trop. 2004;90:55–60. 14739023

20. Aubouy A, Fievet N, Bertin G, Sagbo JC, Kossou H, Kinde-Gazard D, et al. Dramatically decreased therapeutic efficacy of chloroquine and sulfadoxine-pyrimethamine, but not mefloquine, in southern Benin. Trop Med Int Health. 2007;12:886–894. 17596256

21. Uhlemann AC, Ramharter M, Lell B, Kremsner PG, Krishna S. Amplification of Plasmodium falciparum multidrug resistance gene 1 in isolates from Gabon. J Infect Dis. 2005;192:1830–1835. 16235185

22. World Health Organization. Guidelines for the treatment of malaria, 3rd edition. Geneva: World Health Organization; 2015.

23. US Centers for Disease Control and Prevention. Update: new recommendations for mefloquine use in pregnancy. 2011 Oct 3 [cited 31 Jul 2013]. Available: http://www.cdc.gov/malaria/new_info/2011/mefloquine_pregnancy.html.

24. Department of Health and Human Services, US Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling: final rule. Docket number FDA-2006-N-0515. Silver Spring (Maryland): US Food and Drug Administration; 2008. Available: http://wwwgpogov/fdsys/pkg/FR-2008-05-29/pdf/E8-11806pdf.

25. Gonzalez R, Hellgren U, Greenwood B, Menendez C. Mefloquine safety and tolerability in pregnancy: a systematic literature review. Malar J. 2014;13:75. doi: 10.1186/1475-2875-13-75 24581338

26. Council for International Organizations of Medical Sciences. International ethical guidelines for biomedical research involving human subjects. Geneva: Council for International Organizations of Medical Sciences; 2002.

27. Nosten F, ter Kuile F, Maelankiri L, Chongsuphajaisiddhi T, Nopdonrattakoon L, Tangkitchot S, et al. Mefloquine prophylaxis prevents malaria during pregnancy: a double- blind, placebo-controlled study. J Infect Dis. 1994;169:595–603. 8158032

28. Bounyasong S. Randomized trial of artesunate and mefloquine in comparison with quinine sulfate to treat P. falciparum malaria pregnant women. J Med Assoc Thai. 2001;84:1289–1299. 11800303

29. Gonzalez R, Mombo-Ngoma G, Ouedraogo S, Kakolwa MA, Abdulla S, Accrombessi M, et al. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV- negative women: a multicentre randomized controlled trial. PLoS Med. 2014;11:e1001733. doi: 10.1371/journal.pmed.1001733 25247709

30. Lissauer T, Clayden G. Illustrated textbook of paediatrics, 4th edition. Philadelphia: Mosby; 2012.

31. Swysen C, Vekemans J, Bruls M, Oyakhirome S, Drakeley C, Kremsner P, et al. Development of standardized laboratory methods and quality processes for a phase III study of the RTS, S/AS01 candidate malaria vaccine. Malar J. 2011;10:223

32. Planche T, Krishna S, Kombila M, Engel K, Faucher JF, Ngou-Milama E, et al. Comparison of methods for the rapid laboratory assessment of children with malaria. Am J Trop Med Hyg. 2001;65:599–602. 15033648

33. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159:702–706. 15033648

34. World Health Organization. WHO child growth standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age. Methods and development. Geneva: World Health Organization; 2006.

35. Vidmar S, Carlin J, Hesketh K, Cole T. Standardizing anthropometric measures in children and adolescents with new functions for egen. Stata J. 2004;4:50–55.

36. (ICH) ICoH. MedDRA Data retrieval and presentation: points to consider. ICH-Endorsed Guide for MedDRA Users on Data Output. Geneva: IFPMA; 2012.

37. Sowunmi A, Oduola AM, Ogundahunsi OA, Fehintola FA, Ilesanmi OA, Akinyinka OO, et al. Randomised trial of artemether versus artemether and mefloquine for the treatment of chloroquine/sufadoxine-pyrimethamine-resistant falciparum malaria during pregnancy. J Obstet Gynaecol. 1998; 18:322–327. 15512100.

38. Briand V, Bottero J, Noel H, Masse V, Cordel H, Guerra J, et al. Intermittent treatment for the prevention of malaria during pregnancy in Benin: a randomized, open-label equivalence trial comparing sulfadoxine-pyrimethamine with mefloquine. J Infect Dis. 2009; 200:991–1001. doi: 10.1086/605474 19656069.

39. Denoeud-Ndam L, Clement MC, Briand V, Akakpo J, Agossou VK, Atadokpede F, et al. Tolerability of mefloquine intermittent preventive treatment for malaria in HIV-infected pregnant women in Benin. J Acquir Immune Defic Syndr. 2012;61:64–72. 22706291

40. Smoak BL, Writer JV, Keep LW, Cowan J, Chantelois JL. The effects of inadvertentexposure of mefloquine chemoprophylaxis on pregnancy outcomes and infants of US Army servicewomen. J Infect Dis. 1997;176:831–833. 9291347

41. Vanhauwere B, Maradit H, Kerr L. Post-marketing surveillance of prophylactic mefloquine (Lariam) use in pregnancy. Am J Trop Med Hyg. 1998;58:17–21. 9452285

42. Schlagenhauf P, Blumentals WA, Suter P, Regep L, Vital-Durand G, Schaerer MT, et al. Pregnancy and fetal outcomes after exposure to mefloquine in the pre- and periconception period and during pregnancy. Clin Infect Dis. 2012;54:e124–e131. doi: 10.1093/cid/cis215 22495078

43. Newman RD, Parise ME, Slutsker L, Nahlen B, Steketee RW. Safety, efficacy and determinants of effectiveness of antimalarial drugs during pregnancy: implications for prevention programmes in Plasmodium falciparum-endemic sub-Saharan Africa. Trop Med Int Health. 2003;8:488–506. 12791054

44. Nosten F, McGready R, d’Alessandro U, Bonell A, Verhoeff F, Menendez C, et al. Antimalarial drugs in pregnancy: a review. Curr Drug Saf. 2006;1:1–15. 18690910

45. United Nations Children’s Fund. Improving child nutrition. The achievable imperative for global progress. New York: United Nations Children’s Fund; 2013.

46. Engebretsen IM, Tylleskar T, Wamani H, Karamagi C, Tumwine JK. Determinants ofinfant growth in Eastern Uganda: a community-based cross-sectional study. BMC Public Health. 2008;8:418. doi: 10.1186/1471-2458-8-418 19102755

47. Masibo PK, Makoka D. Trends and determinants of undernutrition among young Kenyan children: Kenya Demographic and Health Survey; 1993, 1998, 2003 and 2008–2009. Public Health Nutr. 2012;15:1715–1727. doi: 10.1017/S1368980012002856 22694984

48. Jones AD, Ickes SB, Smith LE, Mbuya MN, Chasekwa B, Heidkamp RA, et al. World Health Organization infant and young child feeding indicators and their associations with child anthropometry: a synthesis of recent findings. Matern Child Nutr. 2014;10:1–17. doi: 10.1111/mcn.12070 23945347

49. Engebretsen IM, Jackson D, Fadnes LT, Nankabirwa V, Diallo AH, Doherty T, et al. Growth effects of exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa: the cluster-randomised PROMISE EBF trial. BMC Public Health. 2014;14:633. doi: 10.1186/1471-2458-14-633 24950759

50. Medhin G, Hanlon C, Dewey M, Alem A, Tesfaye F, Worku B, et al. Prevalence and predictors of undernutrition among infants aged six and twelve months in Butajira, Ethiopia: the P-MaMiE Birth Cohort. BMC Public Health. 2010;10:27. doi: 10.1186/1471-2458-10-27 20089144

51. Matanda DJ, Mittelmark MB, Kigaru DM. Child undernutrition in Kenya: trend analyses from 1993 to 2008–09. BMC Pediatr. 2014;14:5. doi: 10.1186/1471-2431-14-5 24410931

52. Abubakar A, Uriyo J, Msuya SE, Swai M, Stray-Pedersen B. Prevalence and risk factors for poor nutritional status among children in the Kilimanjaro region of Tanzania. Int J Environ Res Public Health. 2012;9:3506–3518. doi: 10.3390/ijerph9103506 23202759

53. Beiersmann C, Bountogo M, Tiendrebeogo J, Louis VR, Gabrysch S, Ye M, et al. Malnutrition in young children of rural Burkina Faso: comparison of survey data from 1999 with 2009. Trop Med Int Health. 2012;17:715–721. doi: 10.1111/j.1365-3156.2012.02985.x 22519807

54. Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012;8:CD003517. doi: 10.1002/14651858.CD003517.pub2 22895934

55. Robinson S, Fall C. Infant nutrition and later health: a review of current evidence. Nutrients. 2012;4:859–874. 23016121

56. Przyrembel H. Timing of introduction of complementary food: short- and long-term health consequences. Ann Nutr Metab. 2012;60(Suppl 2):8–20. doi: 10.1159/000336287 22555185

57. Wright CM, Parkinson KN, Drewett RF. Why are babies weaned early? Data from a prospective population based cohort study. Arch Dis Child. 2004;89:813–816. 15321854

58. Aina OF, Morakinyo O. The validation of Developmental Screening Inventory (DSI) on Nigerian children. J Trop Pediatr. 2001;47:323–328. 11827298

59. Abubakar A, Holding P, van Baar A, Newton CR, van de Vijver FJ. Monitoring psychomotor development in a resource-limited setting: an evaluation of the Kilifi Developmental Inventory. Ann Trop Paediatr. 2008;28:217–226. doi: 10.1179/146532808X335679 18727851

60. Frankenburg WK. The Denver Developmental Screening Test. Dev Med Child Neurol. 1969;11:260–262. 5787726

61. Greenwood AM, Armstrong JR, Byass P, Snow RW, Greenwood BM. Malaria chemoprophylaxis, birth weight and child survival. Trans R Soc Trop Med Hyg. 1992;86:483–485. 1475810

62. Luxemburger C, McGready R, Kham A, Morison L, Cho T, Chongsuphajaisiddhi T, et al. Effects of malaria during pregnancy on infant mortality in an area of low malaria transmission. Am J Epidemiol. 2001;154:459–465. 11532788

63. Verhoeff FH, Le Cessie S, Kalanda BF, Kazembe PN, Broadhead RL, Brabin BJ. Post- neonatal infant mortality in Malawi: the importance of maternal health. Ann Trop Paediatr. 2004;24:161–169. 15186545

64. Nosten F, Vincenti M, Simpson J, Yei P, Thwai KL, de Vries A, et al. The effects of mefloquine treatment in pregnancy. Clin Infect Dis. 1999;28:808–815. 10825043

65. Sidze LK, Faye A, Tetang SN, Penda I, Guemkam G, Ateba FN, et al. Different factors associated with loss to follow-up of infants born to HIV-infected or uninfected mothers: observations from the ANRS 12140-PEDIACAM study in Cameroon. BMC Public Health. 2015;15:228. doi: 10.1186/s12889-015-1555-2 25886161

66. Kalembo FW, Zgambo M. Loss to followup: a major challenge to successful implementation of prevention of mother-to-child transmission of HIV-1 programs in sub-Saharan Africa. ISRN AIDS. 2012;2012:589817. doi: 10.5402/2012/589817 24052879

67. Sibanda EL, Weller IV, Hakim JG, Cowan FM. The magnitude of loss to follow-up of HIV-exposed infants along the prevention of mother-to-child HIV transmission continuum of care: a systematic review and meta-analysis. AIDS. 2013;27:2787–2797. doi: 10.1097/QAD.0000000000000027 24056068

68. United Nations Children’s Fund, World Health Organization, World Bank Group, United Nations. Levels and trends in child mortality: report 2015. New York: United Nations Children’s Fund; 2015.