2024-03-29T05:11:35Z
https://nagoya.repo.nii.ac.jp/oai
oai:nagoya.repo.nii.ac.jp:00028240
2023-11-16T02:57:29Z
499:508:509:2418
Design of a prospective multicenter randomized controlled trial evaluating the effects of gastric lavage on coffee-ground emesis in neonates: study protocol
Maeda, Takashi
92012
Sato, Yoshiaki
92013
Hirakawa, Akihiro
92014
Nakatochi, Masahiro
92015
Kinoshita, Fumie
92016
Suzuki, Takeshi
92017
Ichimura, Shintaro
92018
Ito, Ryoichi
92019
Kudo, Ryuji
92020
Suzuki, Michio
92021
Hoshino, Shin
92022
Sugiyama, Yuichiro
92023
Muramatsu, Hideki
92024
Kidokoro, Hiroyuki
92025
Kawada, Jun-ichi
92026
Takahashi, Yoshiyuki
92027
Nagoya, Collaborative Clinical Research Team
92028
gastric lavage
feeding intolerance
coffee-ground emesis
false melena
2019-05
Neonates who swallow a considerable amount of maternal blood may exhibit vomiting and suckling disorder during the first few days of the postnatal period. Some clinicians treat these neonates with gastric lavage (GL) to prevent vomiting and the establishment of enteral feeding empirically, but there was no study assessing the effect of GL for neonates with coffee-ground emesis. We designed a multicenter randomized controlled trial to evaluate the efficacy and safety of GL in neonates with coffee-ground emesis. Vigorous neonates with birth weight ranging from 2500 g to 3999 g and gestational age between 37w0d and 41w6d who presented with coffee-ground emesis on more than twice and diagnosed as false melena, were divided into two groups using computerized randomization. We defined feeding intolerance (FI) as (1) ≥2 vomiting episodes in 4h or ≥3 episodes in 24h and/or (2) feeding failure on at least two occasions because of retching or poor sucking. Primary outcome is percentage of infants who present FI within 24 hours from admission. We also assessed the residual volumes, number of vomiting episodes, percentage of weight reduction at postnatal day 4, rates of body weight gain at 1 month of age, and peak serum total bilirubin value before discharge. To our knowledge, this is the first study to evaluate the safety and efficacy of GL for neonates with coffee-ground emesis. This trial is registered at UMIN Clinical Trials Registry as UMIN000026483.
departmental bulletin paper
Nagoya University Graduate School of Medicine, School of Medicine
2019-05
Nagoya Journal of Medical Science
2
81
227
232
2186-3326
0027-7622
eng
http://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/812.html
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