Agudelo-Pérez S, Aguirre-Díaz LM, Valderrama-López MA, Jaller-Duarte MF, Buitrago-Reyes L, Gamboa-Garay Ó

Language: Spanish
References: 21
Page: 126-131
PDF size: 248.09 Kb.

ABSTRACT

Introduction: Skin-to-skin contact (STSC) at the birth of the mother-newborn (NB) binomial has a positive impact on achieving exclusive breastfeeding (BF), however, the effectiveness and safety of the STSC given immediately or when it occurs early (one hour after birth) is unknown. Objective: To conduct the interim analysis of a randomized clinical trial (RCT), which compares the STSC immediate vs STSC early, to determine which is more effective (rate of exclusive BF in the first three months of life) and safe (neonatal physiological stability and complications). Material and methods: RCT carried out in two hospitals in Colombia, from November 2018 to July 2019. At-term healthy newborns were included. Safety was assessed in the neonatal period, by monitoring vital signs. Regarding BF, what happened in the first 24 hours was recorded; later, the mothers were contacted by telephone after one week of life and monthly. Results: 150 patients were evaluated, 75 in each STSC group. No statistically significant differences were found in the frequency of exclusive breastfeeding at any of the moments evaluated. There were also no complications in the two study groups. Conclusions: At half the calculated sample size of the RCT, the interim analysis shows that there is no difference in terms of effectiveness and safety between immediate and early CPP, thus there is no ethical objection to continuing patient recruitment. Therefore, this RCT can be completed, as originally planned.

REFERENCES

1. Lactancia materna. Nutrición. UNICEF [Internet]. [Cited 2019 May 23]. Available from: https://www.unicef.org/spanish/nutrition/index_24824.html.

2. NEOVITA Study Group. Timing of initiation, patterns of breastfeeding, and infant survival: prospective analysis of pooled data from three randomised trials. Lancet Glob Health. 2016; 4(4): e266-275.

3. Encuesta Nacional de la Situación Nutricional-ENSIN 2015.

4. Moore ER, Anderson GC, Bergman N. Early skin-to-skin contact for mothers and their healthy newborn infants. In: Moore ER, editor. Cochrane Database of Systematic Reviews. Chichester, UK: John Wiley & Sons, Ltd; 2007.

5. Whitelaw A, Sleath K. Myth of the marsupial mother: home care of very low birth weight babies in Bogota, Colombia. Lancet. 1985; 1(8439): 1206-1208.

6. Andres V, Garcia P, Rimet Y, Nicaise C, Simeoni U. Apparent life-threatening events in presumably healthy newborns during early skin-to-skin contact. Pediatrics. 2011; 127(4): e1073-1076.

7. Abdulghani N, Edvardsson K, Amir LH. Worldwide prevalence of mother-infant skin-to-skin contact after vaginal birth: a systematic review. PLoS One. 2018; 13(10): 1-19. Available from: https://doi.org/10.1371/journal.pone.0205696.

8. Thukral A, Sankar MJ, Agarwal R, Gupta N, Deorari AK, Paul VK. Early skin-to-skin contact and breast-feeding behavior in term neonates: a randomized controlled trial. Neonatology. 2012; 102(2): 114-119.

9. Agudelo S, Gamboa O, Rodríguez F, Cala S, Gualdrón N, Obando E et al. The effect of skin-to-skin contact at birth, early versus immediate, on the duration of exclusive human lactancy in full-term newborns treated at the Clínica Universidad de La Sabana: study protocol for a randomized clinical trial. Trials. 2016; 17(1): 521.

10. Kumar A, Chakraborty BS. Interim analysis: a rational approach of decision making in clinical trial. J Adv Pharm Technol Res. 2016; 7(4): 118-122.

11. Feldman-Winter L, Goldsmith JP, Committee on fetus and newborn COFA, task force on sudden infant death syndrome tfosid. Safe sleep and skin-to-skin care in the neonatal period for healthy term newborns. Pediatrics. 2016; 138(3): e20161889.

12. Muñoz N SR, Bangdiwala SI. Análisis interino en ensayos clínicos: una guía metodológica. Rev Médica Chile. 2000; 128(8): 935-941.

13. O’Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979; 35(3): 549-556.

14. Ministerio de Protección Social. Guía de Práctica Clínica de Atención al Recién Nacido Sano.: 358. Available from: http://gpc.minsalud.gov.co/gpc_sites/Repositorio/Conv_500/GPC_rns/gpc_rns_completa.aspx.

15. Moore ER, Bergman N, Anderson GC, Medley N. Early skin-to-skin contact for mothers and their healthy newborn infants. Cochrane Database Syst Rev. 2016; 11: CD003519.

16. Gnigler M, Ralser E, Karall D, Reiter G, Kiechl-Kohlendorfer U. Early sudden unexpected death in infancy (ESUDI)--three case reports and review of the literature. Acta Paediatr Oslo Nor 1992. 2013; 102(5): e235-238.

17. Ingram J, Johnson D, Copeland M, Churchill C, Taylor H. The development of a new breast feeding assessment tool and the relationship with breast feeding self-efficacy. Midwifery. 2015; 31(1): 132-137. doi:10.1016/j.midw.2014.07.001

18. Karimi FZ, Sadeghi R, Maleki-Saghooni N, Khadivzadeh T. The effect of mother-infant skin to skin contact on success and duration of first breastfeeding: a systematic review and meta-analysis. Taiwan J Obstet Gynecol. 2019; 58(1): 1-9.

19. Aghdas K, Talat K, Sepideh B. Effect of immediate and continuous mother-infant skin-to-skin contact on breastfeeding self-efficacy of primiparous women: a randomised control trial. Women Birth. 2014; 27(1): 37-40.

20. Fardig JA. A comparison of skin-to-skin contact and radiant heaters in promoting neonatal thermoregulation. J Nurse Midwifery. 1980; 25(1): 19-28.

21. Srivastava S, Gupta A, Bhatnagar A, Dutta S. Effect of very early skin to skin contact on success at breastfeeding and preventing early hypothermia in neonates. Indian J Public Health. 2014; 58(1): 22.