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Saline Enema Administration in Meconium Obstruction of Prematurity and Impact on the Resolution, Feeds, Microbiome, and Gut-brain Axis.

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ClinicalTrials.gov Identifier: NCT06048614

Recruitment Status : Recruiting

First Posted : September 21, 2023

Last Update Posted : March 12, 2024

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Singapore General Hospital

Genome Institute of Singapore

Translational Immunology Institute

Duke-NUS Graduate Medical School

Information provided by (Responsible Party):

Thowfique Kadavukarayil Ibrahim, KK Women's and Children's Hospital

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	July 31, 2026
Estimated Study Completion Date :	December 2026

Publications:

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Chathas MK, Paton JB, Fisher DE. Percutaneous central venous catheterization. Three years' experience in a neonatal intensive care unit. Am J Dis Child. 1990 Nov;144(11):1246-50. doi: 10.1001/archpedi.1990.02150350078030.

Stoll BJ, Gordon T, Korones SB, Shankaran S, Tyson JE, Bauer CR, Fanaroff AA, Lemons JA, Donovan EF, Oh W, Stevenson DK, Ehrenkranz RA, Papile LA, Verter J, Wright LL. Late-onset sepsis in very low birth weight neonates: a report from the National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1996 Jul;129(1):63-71. doi: 10.1016/s0022-3476(96)70191-9.

Shim SY, Kim HS, Kim DH, Kim EK, Son DW, Kim BI, Choi JH. Induction of early meconium evacuation promotes feeding tolerance in very low birth weight infants. Neonatology. 2007;92(1):67-72. doi: 10.1159/000100804. Epub 2007 Mar 14.

Krasna IH, Rosenfeld D, Salerno P. Is it necrotizing enterocolitis, microcolon of prematurity, or delayed meconium plug? A dilemma in the tiny premature infant. J Pediatr Surg. 1996 Jun;31(6):855-8. doi: 10.1016/s0022-3468(96)90153-0.

Emil S, Nguyen T, Sills J, Padilla G. Meconium obstruction in extremely low-birth-weight neonates: guidelines for diagnosis and management. J Pediatr Surg. 2004 May;39(5):731-7. doi: 10.1016/j.jpedsurg.2004.01.027.

Haiden N, Norooz F, Klebermass-Schrehof K, Horak AS, Jilma B, Berger A, Repa A. The effect of an osmotic contrast agent on complete meconium evacuation in preterm infants. Pediatrics. 2012 Dec;130(6):e1600-6. doi: 10.1542/peds.2011-3634. Epub 2012 Nov 26.

Broussard DL. Gastrointestinal motility in the neonate. Clin Perinatol. 1995 Mar;22(1):37-59.

Dumont RC, Rudolph CD. Development of gastrointestinal motility in the infant and child. Gastroenterol Clin North Am. 1994 Dec;23(4):655-71.

Campbell BG, Couceyro P, Keana JF, Weber E. N-methyl-D-aspartate receptor-mediated contractions of the guinea pig ileum longitudinal muscle/myenteric plexus preparation: modulation by phencyclidine and glycine receptors. J Pharmacol Exp Ther. 1991 May;257(2):754-66.

Siddiqui MM, Drewett M, Burge DM. Meconium obstruction of prematurity. Arch Dis Child Fetal Neonatal Ed. 2012 Mar;97(2):F147-50. doi: 10.1136/adc.2010.190157. Epub 2010 Nov 29.

Juang D, Snyder CL. Neonatal bowel obstruction. Surg Clin North Am. 2012 Jun;92(3):685-711, ix-x. doi: 10.1016/j.suc.2012.03.008. Epub 2012 Apr 17.

Kim YJ, Kim EK, Kim ES, Kim HS, Choi JH, Cheon JE, Kim WS, Kim IO, Park KW. Recognition, diagnosis and treatment of meconium obstruction in extremely low birth weight infants. Neonatology. 2012;101(3):172-8. doi: 10.1159/000330850. Epub 2011 Oct 22.

Garza-Cox S, Keeney SE, Angel CA, Thompson LL, Swischuk LE. Meconium obstruction in the very low birth weight premature infant. Pediatrics. 2004 Jul;114(1):285-90. doi: 10.1542/peds.114.1.285.

Cho HH, Cheon JE, Choi YH, Lee SM, Kim WS, Kim IO, Shin SM, Kim EK, Kim HS, Choi JH, You SK. Ultrasound-guided contrast enema for meconium obstruction in very low birth weight infants: Factors that affect treatment success. Eur J Radiol. 2015 Oct;84(10):2024-31. doi: 10.1016/j.ejrad.2015.06.006. Epub 2015 Jun 7.

Ibrahim T, Li Wei C, Bautista D, Sriram B, Xiangzhen Fay L, Rajadurai VS. Saline Enemas versus Glycerin Suppositories to Promote Enteral Feeding in Premature Infants: A Pilot Randomized Controlled Trial. Neonatology. 2017;112(4):347-353. doi: 10.1159/000477999. Epub 2017 Aug 3.

Paradiso VF, Briganti V, Oriolo L, Coletta R, Calisti A. Meconium obstruction in absence of cystic fibrosis in low birth weight infants: an emerging challenge from increasing survival. Ital J Pediatr. 2011 Nov 14;37:55. doi: 10.1186/1824-7288-37-55.

Livingston MH, Shawyer AC, Rosenbaum PL, Williams C, Jones SA, Walton JM. Glycerin enemas and suppositories in premature infants: a meta-analysis. Pediatrics. 2015 Jun;135(6):1093-106. doi: 10.1542/peds.2015-0143. Epub 2015 May 18.

Vinson AE, Houck CS. Neurotoxicity of Anesthesia in Children: Prevention and Treatment. Curr Treat Options Neurol. 2018 Oct 13;20(12):51. doi: 10.1007/s11940-018-0536-z.

Saenz de Pipaon Marcos M, Teresa Montes Bueno M, Sanjose B, Gil M, Parada I, Amo P. Randomized controlled trial of prophylactic rectal stimulation and enemas on stooling patterns in extremely low birth weight infants. J Perinatol. 2013 Nov;33(11):858-60. doi: 10.1038/jp.2013.86. Epub 2013 Aug 1.

Nakaoka T, Nishimoto S, Tsukazaki Y, Santo K, Higashio A, Kamiyama M, Uehara S, Yoneda A, Tanaka Y, Ichiba H. Ultrasound-guided hydrostatic enema for meconium obstruction in extremely low birth weight infants: a preliminary report. Pediatr Surg Int. 2017 Sep;33(9):1019-1022. doi: 10.1007/s00383-017-4129-9. Epub 2017 Jul 25.