NCT04639518已完成不适用
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants: a Multi-centered, Open-label Clinical Trial
Société des Produits Nestlé (SPN)4 个研究点 分布在 3 个国家目标入组 28 人开始时间: 2020年9月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Growth
研究概览
简要总结
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).
详细描述
This is a multi-center, open-label trial to be conducted in up to 70 pre-term infants in order to evaluate the safety and suitability of two feeding systems as they would typically be used in the neonatal care unit. Growth (in comparison to recommended growth goals), feeding tolerance, biochemical parameters, and adverse event reporting will be evaluated.
The two feeding systems will be tested in two sub-studies to be conducted sequentially: sub-study 1 will evaluate a two-staged feeding system with HMOs in up to 35 pre-term infants; sub-study 2 will evaluate a two-staged feeding system without HMOs in up to 35 pre-term infants.
A follow up period from 12 to 24 months have been added to the study protocol, to assess the neurocognitive development of the subjects during this period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
- •Infants' birth weight ≤1500 g and AGA.
- •Infant's gestational age < 37 weeks.
- •Infant is clinically stable and does not have deteriorating respiratory function after birth.
- •Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.
排除标准
- •Parent(s) not willing / not able to comply with the requirements of study protocol.
- •Infant is experiencing early onset sepsis.
- •Major congenital or chromosomal abnormality known to affect growth.
- •Liver failure.
- •Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).
- •Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk.
- •Infant's participation in another interventional clinical trial.
- •Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).
研究组 & 干预措施
Sub-study 1
Experimental
Pre-term formulas with HMO
干预措施: Preterm formulas with HMO (Other)
Sub-study 2
Experimental
Pre-term formulas without HMO
干预措施: Preterm formulas without HMO (Other)
结局指标
主要结局
Growth
时间窗: From FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier
Weight-adjusted weight gain (g/kg/day)
次要结局
- Other growth parameter (head circumference)(From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months)
- Anthropometric z-scores for weight, length and head circumference(From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months)
- Feeding intake at neonatal unit(Baseline + weekly over 3 consecutive days starting on pre-FEF Day1 + weekly over 3 consecutive days starting on FEF Day1 until Neonatal Unit Discharge (on average 7 weeks after birth))
- Stool frequency at neonatal unit(Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth))
- Bloody stools at neonatal unit(Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth))
- Feeding intake after discharge(3 consecutive days just prior to the 30-day PD and 60-day PD visits)
- GI symptoms after discharge(3 consecutive days just prior to the 30-day PD and 60-day PD visits)
- Serum biomarkers for bone health(At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD)
- Stool frequency after discharge(3 consecutive days just prior to the 30-day PD and 60-day PD visits)
- Stool consistency after discharge(3 consecutive days just prior to the 30-day PD and 60-day PD visits)
- Feeding patterns(At 12, 18, and 24 months)
- Weight at other time points(From Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months)
- Other growth parameter (length)(From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months)
- Stool consistency at neonatal unit(Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth))
- GI-related behaviors after discharge(3 consecutive days just prior to the 30-day PD and 60-day PD visits)
- Serum biomarkers for protein status(At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD)
- Fecal markers for gut health / maturation and immune status(Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD)
- Urine markers for gut health / maturation and immune status(Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD)
- Developmental Milestone scores(At 12, 18, and 24 months)
- GI symptoms at neonatal unit(Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth))
- Urine biomarkers for bone health(At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD)
- Vitamin D(FEF Day 1, Neonatal Unit Discharge and at 60 days PD)
- Fecal microbiota(Baseline, FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, at 30 day-PD and 60 days PD)
- AE reporting(From the time the mother has consented to the infant's participation in the study until the 60 days PD visit)
- Bayley-III scores(At 12, 18, and 24 months)
- Child temperament scores(At 12, 18, and 24 months)
- Number of healthcare usage(At 12, 18, and 24 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
1 期
A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)Cystic FibrosisNCT06299709Vertex Pharmaceuticals Incorporated34
已完成
1 期
Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese VolunteersHealthy VolunteersNCT05249348PMV Pharmaceuticals, Inc34
已完成
1 期
Single Dose Bioavailability and Ethnobridging PK Study in Healthy SubjectsBowel Diseases, InflammatoryIntestinal DisorderNCT04587713Theravance Biopharma58
已完成
2 期
A Study of Different Formulations of the L-PPDS in Subjects With OH or OAGGlaucomaOcular HypertensionNCT00967811Mati Therapeutics Inc.83
已完成
1 期
Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy SubjectsHealthyNCT02392702Concert Pharmaceuticals15