Efficacy and Safety of Refeeding in Preterm Infants With Enterostomy

Перакладаць артыкулы могуць толькі зарэгістраваныя карыстальнікі

Увайсці / Зарэгістравацца

Спасылка захоўваецца ў буферы абмену

СтатусВербаванне

Спонсары

Seoul National University Hospital

КЛІНІЧНАЕ ВЫПРАБАВАННЕ: NCT02812095

BioSeek: NCT02812095

Ключавыя словы

Рэферат

Refeeding is an extracorporeal stool transport from the proximal stoma end to the distal end of stoma. Refeeding may be beneficial in preventing malabsorption, electrolyte imbalance, cholestasis and atrophy of the distal intestine. Investigators are focused on evaluating the efficacy and safety of the practice of refeeding in preterm infants with enterostomy. Clinical data including weight gain, total parenteral nutrition (TPN) usage, and other laboratory findings will be collected. Serial citrulline levels during refeeding procedure and pathologic specimens of bowel (at the time of stoma closure) will be collected for evaluating bowel adaptation.

Даты

Апошняя праверка:	03/31/2019
Упершыню прадстаўлена:	06/05/2016
Меркаваная колькасць заявак прадстаўлена:	06/20/2016
Першае паведамленне:	06/23/2016
Апошняе абнаўленне адпраўлена:	04/02/2019
Апошняе абнаўленне апублікавана:	04/03/2019
Фактычная дата пачатку даследавання:	07/31/2014
Разліковая дата першаснага завяршэння:	12/30/2020
Разліковая дата завяршэння даследавання:	12/30/2020

Стан альбо хвароба

Enterostomy

Ўмяшанне / лячэнне

Procedure: The refeeding group

Фаза

Групы ўзбраенняў

Рука	Ўмяшанне / лячэнне
Experimental: The refeeding group Refeeding is initiated when 120mL/kg/day of enteral feed reaches or stoma loss exceeds more than 40ml/kg/day after operation.	Procedure: The refeeding group when amount of feeding reach to 120mL/kg a day,
No Intervention: The control group

Крытэрыі прыдатнасці

Пол, прыдатны для навучання

All

Прымае здаровых валанцёраў

Так

Крытэрыі

Inclusion Criteria:

- Preterm infants who are less than 35 weeks gestational age at birth and get stomas after laparotomy

Exclusion Criteria:

- Congenital gastrointestinal malformation

- Blind pouch (after laparotomy)

- Refeeding procedure related infection

- Hemodynamic instability requiring inotropic or vasopressor agents (if the condition improves, the refeeding procedure can be restarted again)

Вынік

Першасныя вынікі

1. The change of citrulline level during the study period [up to 6 months of corrected age]

4 time points: at the time of full enteral feeding (>120 cc/kg/day), 4 weeks later after full enteral feeding, at the time of stoma closure operation, 12 weeks later after closure operation

Меры другаснага выніку

1. The pathologic findings after refeeding procedure [up to 8 weeks of corrected age]

villus height, crypt depth, mucosal thickening of pathologic specimens at the time of stoma closure operation

2. the number of days on parenteral nutrition [up to 8 weeks of corrected age]

the day of discontinuation of intravenous protein supplements

3. The weight gain [up to 6 months of corrected age]

differences in the admission weight Z-scores and end of study weight Z-scores

4. Adverse events during refeeding procedure [up to 8 weeks of corrected age]

bowel prolapse, enteral hemorrhage, abdominal distension, infection related stoma