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הניסוי הקליני NCT07045844 עבור Very Preterm Infant, Necrotizing Enterocolitis (NEC) הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
השפעות של משטרי הזנה אנטרלית על NEC, תמותה והתפתחות נוירולוגית בפגים מאוד 2,324 אקראי נתוני עולם אמיתי תווית פתוחה
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07045844 הוא מחקר מסוג התערבותי עבור Very Preterm Infant, Necrotizing Enterocolitis (NEC), שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-2 במרץ 2026, במטרה לכלול 2,324 משתתפים. המחקר ינוהל על ידי The Children's Hospital of Zhejiang University School of Medicine וצפוי להסתיים ב-31 ביולי 2030. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-24 בפברואר 2026.
סיכום קצר
The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born before 29 weeks of gestation. It also aims to assess whether routine use of human milk fortifiers benefits this population. The main questions it aims to answer are:
Does supplementing OMM ...
הצג עודכותרת רשמית
The Effects of Different Enteral Feeding Regimens on Necrotizing Enterocolitis, Mortality, and Neurodevelopment in Very Preterm Infants: A Multicenter Double-Randomized Trial
מצבים רפואיים
Very Preterm InfantNecrotizing Enterocolitis (NEC)מזהי מחקר נוספים
- 2025-IRB-0232-P-03
מספר NCT
תחילת המחקר (בפועל)
2026-03-02
עדכון אחרון שפורסם
2026-02-24
סיום המחקר (מוערך)
2030-07-31
משתתפים (מתוכנן)
2,324
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
טרם החל גיוס
מטרה ראשית
מניעה
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיPasteurized Donor Milk for Insufficient Breastfeeding Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient. | Pasteurized Donor Milk for Insufficient Breastfeeding Participants receive pasteurized donor human milk (pHDM) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply. Routine fortification Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk \[OMM\] and/or donor pasteurized human milk \[pHDM\] ) reaches between 60-120 mL/kg Rescue fortification Randomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL/kg/day of breast milk or formula. Blood urea levels in these infants remain consisten...הצג עוד |
ניסיPreterm formula for Insufficient Breastfeeding Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient. | Preterm Formula for Insufficient Breastfeeding Participants receive preterm formula (PTF) as supplemental feeding when the clinician determines maternal milk supply is insufficient.
Randomization 1 will occur when the clinician determines that supplemental feeding is required due to insufficient breast milk supply. Routine fortification Randomization 2 will be conducted when the total daily intake of human milk (including own mother's milk \[OMM\] and/or donor pasteurized human milk \[pHDM\] ) reaches between 60-120 mL/kg Rescue fortification Randomization 2 will be conducted: Add fortifiers when the infant meets predefined criteria for growth faltering (Preterm infants exhibit a sustained decline in growth velocity for weight, length, or head circumference, demonstrated by a downward crossing of centiles on growth curves, despite tolerating and consuming at least 180 mL/kg/day of breast milk or formula. Blood urea levels in these infants remain consisten...הצג עוד |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Survival without surgical NEC | Survival to 34 weeks corrected gestational age without surgical necrotizing enterocolitis (NEC) | 34 weeks corrected gestational age |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
NEC requiring surgical intervention | 34 weeks gestational age | |
Survival | 28 days after birth | |
Survival that occurred during hospitalization | Survival: Survival outcome indicators measure the success of enduring life-threatening conditions, eg. survival rate. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Medically treated NEC that occurred during hospitalization | Medically treated NEC: Diagnosis of necrotizing enterocolitis that required medical (non-surgical) treatment, such as bowel rest and antibiotic therapy. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Treated retinopathy of prematurity (ROP) that occurred during hospitalization | Treated retinopathy of prematurity (ROP): ROP that progressed to a stage requiring medical or surgical intervention, including laser therapy or intravitreal injections. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Hearing impairment that occurred during hospitalization | Hearing impairment: Documented hearing loss identified through newborn hearing screening or diagnostic audiology tests, potentially requiring follow-up or intervention. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Severe brain injury that occurred during hospitalization | Severe brain injury: Presence of significant brain injury such as Grade III or IV intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL) as diagnosed by cranial imaging. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Length of hospital stay | Length of hospital stay: Total number of days from birth until discharge from the hospital. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Number of episodes of bloodstream infection that occurred during hospitalization | Number of episodes of bloodstream infection: Total number of confirmed bloodstream infections (positive blood cultures) during the hospital stay. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Events that occurred during hospitalization | Number of days of antibiotic treatment: Cumulative number of days the infant received systemic antibiotic therapy during hospitalization. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Number of days on parenteral nutrition that occurred during hospitalization | Number of days on parenteral nutrition: Total number of days the infant received intravenous nutritional support due to inability to tolerate full enteral feeds. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Number of days of NPO that occurred during hospitalization | Number of days of NPO: Total number of days the infant was designated "nil per os" (NPO), meaning no enteral feeding was given. | From birth until hospital discharge (up to approximately 44 weeks postmenstrual age) |
Body weight | Growth parameters (weight): Measurements of the infant's body weight at 2 years corrected age. | From birth until 2 years corrected age. |
Body length | Body length: Measurements of the infant's body length at 2 years corrected age. | From birth until 2 years corrected age. |
Head circumference | Head circumference: Measurements of the infant's head circumference at 2 years corrected age. | From birth until 2 years corrected age. |
Parent Report of Children's Abilities-Revised (PARCA-R) assessment | Survival without moderate to severe cognitive or language impairment. PARCA-R stands for Parent Report of Children's Abilities-Revised. It is a parent completed questionnaire that can be used to assess children's cognitive and language development at 24 months of age. | At 2 years corrected age |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד
גיל מינימלי למחקר
1 Day
מגדרים מוערכים למחקר
הכל
- Gestational age at birth less than 29 weeks;
- No contraindications to enteral feeding;
- Mother is willing to breastfeed.
- For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers;
- For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;
The Children's Hospital of Zhejiang University School of Medicineאימפריאל קולג'235 מחקרים פעילים לחקורהגורם האחראי למחקר
Yanping Xu, חוקר ראשי, Dr., The Children's Hospital of Zhejiang University School of Medicine
איש קשר מרכזי למחקר
איש קשר: Yanping Xu, 8613685757726, [email protected]
22 מיקומי המחקר ב-1 מדינות
Guangxi
The First Affiliated Hospital of Guilin Medical University, Guilin, Guangxi, China
Yuan Tan, איש קשר, 13707837294
Yuan Tan, חוקר ראשי
Yongjie Liao, חוקר משנה
The Second Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, 530007, China
Qiaozhen Wei, איש קשר, 15994596410
Qiaozhen Wei, חוקר ראשי
Yulin Maternity and Child Health Care Hospital, Guangxi, Yulin, Guangxi, 537000, China
Yaoxun Wu, איש קשר, 13768963338
Yaoxun Wu, חוקר ראשי
Guiyang
The Affiliated Hospital of Guizhou Medical University, Guizhou, Guiyang, 550001, China
Shilan Xiao, איש קשר, 18984355441
Shilan Xiao, חוקר ראשי
Henan
Nanyang Central Hospital, Nanyang, Henan, 473000, China
Ping Zhu, איש קשר, 13569272770
Ping Zhu, חוקר ראשי
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Qianya Xu, איש קשר, 13203805371
Qianya Xu, חוקר ראשי
Hunan
Yiyang Central Hospital, Yiyang, Hunan, China
Xianglian Liu, איש קשר, 15898439990
Xianglian Liu, חוקר ראשי
Jiangxi
Ganzhou Maternal and Child Health Hospital, Ganzhou, Jiangxi, China
Xiaohua Luo, איש קשר, 18079708860
Xiaohua Luo, חוקר ראשי
Ningxia
Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital), Yinchuan, Ningxia, China
Yuhua Wu, איש קשר, 17709589568
Yuhua Wu, חוקר ראשי
Shandong
Shandong Provincial Maternal and Child Health Care Hospital, Jinan, Shandong, China
Zhengxia Wan, איש קשר, 15153167517
Zhengxia Wan, חוקר ראשי
Sichuan
Sichuan Provincial Maternal and Child Health Hospital, Chengdu, Sichuan, 610045, China
Jingmei Hao, איש קשר, 18280350267
Jingmei Hao, חוקר ראשי
The Affiliated Hospital of Southwest Medical University, Luzhou, Sichuan, China
Lan Kang, איש קשר, 13982762269
Lan Kang, חוקר ראשי
Xinjiang Uygur Autonomous Region
People's Hospital of Xinjiang Uygur Autonomous Region, Ürümqi, Xinjiang Uygur Autonomous Region, China
Jinfeng He, איש קשר, 13565924349
Jinfeng He, חוקר ראשי
Zhejiang
Yongkang Maternity and Child Health Care Hospital, Guli, Zhejiang, 321300, China
Aijuan Yang, איש קשר, 8613506790182, [email protected]
Aijuan Yang, חוקר ראשי
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 0571, China
Zheng Chen, איש קשר, 0571-13857151000, [email protected]
Zheng Chen, חוקר ראשי
Yanping Xu, חוקר ראשי
Daqing Ma, חוקר ראשי
Lizhong Du, חוקר ראשי
Mingyan Chen, חוקר משנה
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310003, China
Fang Luo, איש קשר, 8613616542920, [email protected]
Fang Luo, חוקר ראשי
Xiaofei Luo, חוקר משנה
Women's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310006, China
Jiajun Zhu, איש קשר, 8613858089111, [email protected]
Jiajun Zhu, חוקר ראשי
Hangzhou Women's Hospital, Hangzhou, Zhejiang, 310008, China
Weinong Mo, איש קשר, 8613606719109, [email protected]
Weinong Mo, חוקר ראשי
jing Li, חוקר משנה
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310016, China
Zhou Jiang, איש קשר, 8613588878072, [email protected]
Zhou Jiang, חוקר ראשי
Jiaxing Maternity and Child Health Care Hospital, Jiaxing, Zhejiang, 314000, China
Huafei Huang, איש קשר, 8613867344127, [email protected]
Huafei Huang, חוקר ראשי
Minjia Zhou, חוקר משנה
Ningbo Women and Children's Hospital (The Affiliated Women and Children's Hospital of Ningbo University), Ningbo, Zhejiang, 315012, China
Qin Lv, איש קשר, 8613738822179, [email protected]
Yanhong Li, חוקר ראשי
Yiwu Maternity and Child Health Care Hospital (Yiwu Branch of The Children's Hospital, Zhejiang University School of Medicine), Yiwu, Zhejiang, 322000, China
Shujun Chen, איש קשר, 8618314930492, [email protected]
Shujun Chen, חוקר ראשי
Cuie Chen, חוקר משנה