NCT05245422已完成不适用
Parent And Infant Relief (PAIR): Acceptance of a Partially Hydrolyzed Formula
Mead Johnson Nutrition21 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2022年2月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 21
- 主要终点
- Fussiness
研究概览
简要总结
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein infant formula on infant fussiness.
详细描述
A multi-center, double-blind, controlled, parallel-designed, prospective trial intended to evaluate the nutritive effects of a partially hydrolyzed cow's milk protein (PHP) infant formula on infant fussiness. Formula tolerance and intake, sleep characteristics, stool characteristics, parental quality of life, and medically confirmed adverse events will be compared between i two study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Days 至 75 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary caregiver has reliable access to the internet and a reliable device (such as a computer, tablet, or smartphone) to access mobile apps and be able to view and complete study questionnaires
- •Singleton birth
- •15 to 75 days of age at Visit 1, inclusive (day of birth is considered Day 0)
- •Gestational age of ≥37 to 42 weeks (36 weeks and six days is considered 36 weeks' gestational age)
- •Birth weight of 2500 g (5 lbs 8 oz) or more
- •Exclusively receiving an intact protein infant formula (cow's milk-based or plant-based) for 7 days prior to Visit 1
- •Answer to question: "On average, how fussy has your baby been over the past 3 days" is moderately fussy, very fussy, or extremely fussy at Visit 1
- •Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
- •Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- •Signed informed consent obtained from parent or legal guardian for infant's participation in the study
- •Signed authorization obtained from parent or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period
排除标准
- •Infant has been weighed by a health care professional (HCP) and is identified with inadequate weight gain or failure-to-thrive
- •Diagnosis or suspicion of cow's milk protein allergy by a healthcare professional
- •Any acute illness within the 3 days prior to Visit 1
- •Infant has had immunizations or a surgical procedure within the 3 days prior to or on Visit 1
- •Immunizations are planned for the infant during any of the 7 days after Visit 1
- •Use of oral, intramuscular or intravenous antibiotics within the 7 days prior to Visit 1
- •Infant has had bloody stools (visible to the naked eye) within the 7 days prior to Visit 1
- •Infant has been taking medication (prescribed and over-the-counter) for gastrointestinal conditions for any of the 7 days prior to Visit 1 (however, probiotics are allowed)
- •Infant has a surgical procedure planned during the study period
- •History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
- •History of underlying neurological or organic disease likely to cause fussiness, such as (but not limited to) a doctor's diagnosis of neonatal abstinence syndrome and inflammatory or orthopedic disorders
- •Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)
结局指标
主要结局
Fussiness
时间窗: Study Feeding Days 1 through 7
Daily Diary
次要结局
- Sleep(Study Feeding Days 1-28)
- Fussiness(Study Feeding Days 8-28)
- Gassiness(Study Feeding Days 1-28)
- Crying(Study Feeding Days 1-28)
- Spit-up(Study Feeding Days 1-28)
- Stool frequency(Study Feeding Days 1-28)
- Stool consistency(Study Feeding Days 1-28)
- Study Formula Intake(Study Feeding Day 7 and Study Feeding Day 25 (+3 days))
- Brief Infant Sleep Questionnaire(Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days))
- Quality of Life Questionnaire(Study Feeding Day 7 (+2 days) and Study Feeding Day 25 (+3 days))
- Medically confirmed adverse events(Day 1 through end of feeding)
研究者
研究点 (21)
Loading locations...
相似试验
已完成
不适用
Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal StrokePerinatal StrokeNCT03672864University of Alberta18
进行中（未招募）
不适用
The Success Rate and Acceptability of Conventional and Modified Hall Crowns Among Children and ParentsPaediatric DentistryDental Caries in ChildrenDental TreatmentNCT06545279King Abdullah University Hospital121
已完成
不适用
Greenlight Plus Study: Approaches to Early Childhood Obesity PreventionBehavior, HealthChild ObesityNCT04042467Vanderbilt University Medical Center900
尚未招募
不适用
Effects of the Couplet Care in Neonatal Intensive Care UnitEarly Skin-to-skin ContactPsychological DistressParentingPreterm InfantNCT05655104Turku University Hospital30
招募中
不适用
Parenting Support Intervention for Families Coping With Metastatic or Locally Recurrent Solid Tumor DiagnosisMetastatic Malignant Solid NeoplasmRecurrent Malignant Solid NeoplasmNCT05059678M.D. Anderson Cancer Center120