Target Weaning Oxygen to Determine Cafffeine Duration for AOP
NCT ID: NCT04868565
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
310 participants
INTERVENTIONAL
2021-05-01
2023-10-15
Brief Summary
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Ideally, the optimal timing of discontinuing caffeine should be individual-specific. Published work has indicated that AOP and intermittent hypoxemia (IH) were frequently observed beyond 36 weeks' PMA in all gestational age groups, particularly in the 24- to 27-week infants \[3, 4\]. In the clinical settings, intermittent hypoxic and AOP episodes is a predominant cause of oxygen supplement in premature infants and commonly prolong the hospital stay. Optimizing arterial saturation by oxygen supplement is essential to achieve a stable cardiorespiratory status because hypoxemia could induce hypoxic sensitivity of the carotid bodies in neonates, resulting in more pronounced ventilatory depression and more frequent apneic episodes. Some RCTs have shown that continuing caffeine administration beyond PMA 34 weeks could reduce the frequency of IH episodes in premature infants \[4, 5\]. Therefore, theoretically, a prolonged caffeine administration over the usual duration could shorten the duration of oxygen supplements in those infants at high risk of frequent late AOP or IH. Target weaning oxygen could be an opportunistic indicator of discontinuing caffeine.
In light of the above considerations, a multicenter, retrospective, partially blinded, controlled trials will be conducted to verify the hypothesis that a novel caffeine regimen that weaning oxygen as the indicator of discontinuing caffeine could improve respiratory outcomes of very premature infants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ongoing caffeine with oxygen supplement (group 1)
samples assigned to the "ongoing caffeine with oxygen supplement (group 1)" will continue caffeine administration combining with oxygen supplement until the patients are weaned from oxygen.
Caffeine Citrate 20 MG/1 ML Intravenous Solution [CAFCIT]
after randomization, caffeine citrate will be contineously prescribed to those patients assigned to the "ongoing caffeine with oxygen supplement (group 2) with a medication regimen of 10mg/kg.dose, once daily, and weekly adjustment based on the working weight.
discontinuing caffeine with oxygen supplement (group 2)
samples assigned to the "discontinuing caffeine with oxygen supplement (group 2)" will discontinue caffeine immediately after randomization, while oxygen supplement is going on.
Caffeine Citrate 20 MG/1 ML Intravenous Solution [CAFCIT]
after randomization, caffeine citrate will be contineously prescribed to those patients assigned to the "ongoing caffeine with oxygen supplement (group 2) with a medication regimen of 10mg/kg.dose, once daily, and weekly adjustment based on the working weight.
Interventions
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Caffeine Citrate 20 MG/1 ML Intravenous Solution [CAFCIT]
after randomization, caffeine citrate will be contineously prescribed to those patients assigned to the "ongoing caffeine with oxygen supplement (group 2) with a medication regimen of 10mg/kg.dose, once daily, and weekly adjustment based on the working weight.
Eligibility Criteria
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Inclusion Criteria
* postmenstral age ≥32weeks
* a history of caffeine therapy
* no current positive pressure respiratory support, and free of apnea for at least five consecutive days, but still oxygen dependent
* parents or legal guardians sign informed consent to attend this study
Exclusion Criteria
* Grade III/IV intraventricular hemorrhage, or probable brain injury attributable to confirmed central nervous system infection, severe periventricular leukomalacia or other entities;
* underwent tracheostomy
* currently on sedatives, opioids, or other medication related to depressed breath
14 Days
6 Months
ALL
No
Sponsors
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Children's Hospital of Chongqing Medical University
OTHER
Responsible Party
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Wang Jianhui
Attending neonatologist
Principal Investigators
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Yuan Shi
Role: STUDY_DIRECTOR
Children's Hospital of Chongqing Medical University
Locations
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The First Affiliated Hospital of USTC（University of Science and Technology of China）
Hefei, Anhui, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Yuan Shi
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Army Military Medical University
Chongqing, Chongqing Municipality, China
Fuling Central Hospital of Chongqing City
Fuling, Chongqing Municipality, China
The People's Hospital of Dazu
Longgang, Chongqing Municipality, China
Chongqing University Three Gorges Hospital
Wanzhou, Chongqing Municipality, China
Chongqing Wanzhou Health Center for Women And Children
Wanzhou, Chongqing Municipality, China
Fuzhou Children's Hospital of Fujian Medical University
Fuzhou, Fujian, China
Xiamen Children's Hospital
Xiamen, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Dongguan City Maternal&Child Health Hospital
Dongguan, Guangdong, China
Maternal and Child Health Hospital of Yunfu
Yunfu, Guangdong, China
Affiliated Hospital Of Guangdong Medical University
Zhanjiang, Guangdong, China
BOAI hospital of Zhongshan
Zhongshan, Guangdong, China
Haikou Hospital of the Maternal and Child Health
Haikou, Hainan, China
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Third Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Hengyang Maternity and Child care hospital
Hengyang, Hunan, China
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
First Affiliation Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The first bethune hospital of Jilin university
Changchun, Jilin, China
Qilu Children's Hospital of ShanDong University
Jinan, Shandong, China
Women & Children's Health Care Hospital of Linyi
Linyi, Shandong, China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Guangyuan central hospital
Guangyuan, Sichuan, China
People's Hospital Of Leshan
Leshan, Sichuan, China
Hospital T. C. M Affiliated to Southwest Medical University
Luzhou, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Panzhihua Central Hospital
Panzhihua, Sichuan, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
Kunming Children's Hospital
Kunming, Yunnan, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Qujing City Maternal and Child Health Hospital
Qujing, Yunnan, China
The People's Hosiptal of Wenshan Prefecture
Wenshan, Yunnan, China
The First People's Hospital of Zhaotong
Zhaotong, Yunnan, China
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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20210326
Identifier Type: -
Identifier Source: org_study_id
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