Early Versus Delayed Cord Clamping at Term: Neurodevelopmental Outcomes in Swedish Infants at 4 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Intelligence quotient (IQ) as measured by the Wechsler Preschool and Primary Scale of Intelligence-III.
研究概览
简要总结
Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared to early clamping, a delay in clamping in clamping of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight to the newborn infant.
The results of previous intervention studies on delayed clamping are mixed, and few have followed the infants beyond the perinatal period. All longer follow up studies have been performed in low income countries except for the investigators earlier study, showing less iron deficiency and improved iron stores after delayed cord clamping at 4 months of age.
The main objective of the current study is to assess whether the time of cord clamping affects neurodevelopment at 4 years of age in a large sample of full-term, Swedish infants. The investigators hypothesis is that as delayed cord clamping improves iron stores at 4 months, this could affect the child's development positively.
详细描述
Project description
Iron deficiency is associated with neurodevelopmental delay and suboptimal cognitive function. Our hypothesis is that early cord clamping is associated with an increased risk for iron deficiency, and as a consequence increased risk for suboptimal infant development also in a country with high standard of living.
- Method
- Study cohort Four-hundred full-term infants, born to healthy mothers after normal pregnancies, were randomized to early or delayed cord clamping (at a hospital which practiced early cord clamping as standard practice). The infants were born during the time-period April 2008 to May 2009. Pregnant women were considered eligible if they met the following criteria: non-smoking, healthy mother (no haemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone), normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection), single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days), expected vaginal delivery with cephalic presentation. Furthermore, the mother should be able to master Swedish well enough to understand the meaning of the study. Mothers were given written and oral information about the trial at the maternal health care centre from 34 weeks of gestational age. Mothers fulfilling the inclusion criteria at the time of admission to the delivery ward were again given written and oral information about the study by the attending midwife and written informed consent was obtained. Randomization was performed in advance by computer in blocks of 20. When delivery was imminent, the midwife opened a sealed envelope containing the treatment allocation. The intervention in the early cord clamping (ECC) group consisted of double clamping of the umbilical cord within 10 seconds of the infant's delivery, and arterial and venous blood sampling from the clamped segment within 10 min. The intervention in the delayed cord clamping (DCC) group consisted of late (≥ 180 s) clamping of the umbilical cord and arterial and venous blood sampling from the unclamped cord within 30 seconds after birth, while the midwife was holding the child below the level of the uterus. In both randomization groups, all children were initially kept about 20 cm below the level of the mother's uterus for 30 seconds and then placed on their mother's chest. All other aspects of obstetric care during labour and delivery were managed according to the standard practice of care at the study hospital. Oxytocin was administered to all mothers immediately after cord clamping. The final participating mother-infant pairs available for statistical analysis were 189 in the ECC group and 193 in the DCC group.
- Follow up at 4 years of age
Children will be asked to return for a follow up at 4 years of age for neuro-developmental testing including:
- Cognitive testing with WPPSI (Wechsler Preschool and Primary Scale of Intelligence)
- Behavioral assessment with SDQ (Strengths and Difficulties Questionnaire), a questionnaire for behavioural screening which is filled in by the parents
- Assessment of psychomotor development with ASQ (Ages and Stages Questionnaire), a questionnaire that is filled in by the parents
- Selected items from Movement ABC (Assessment Battery for Children)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 48 Months 至 51 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant in the earlier cord clamping trial
- •Age between 48 and 51 months
排除标准
- 未提供
结局指标
主要结局
Intelligence quotient (IQ) as measured by the Wechsler Preschool and Primary Scale of Intelligence-III.
时间窗: 48 months (plus 3 months)
The Wechsler Preschool and Primary Scale of Intelligence (WPPSI) is an intelligence test designed for children ages 2 years 6 months to 7 years 3 months. A trained and experienced psychologist will perform the test and do the evaluation.
次要结局
- Score of the different subsets of Wechsler Preschool and Primary Scale of Intelligence-III.(48 months (plus 3 months))
- Fine motor skills assessed by the Movement Assessment Battery for Children-Second Edition.(48 months (plus 3 months))
- Gender effect on the result of the developmental tests.(48 months (plus 3 months))
- Psychomotor development assessed by the Ages and Stages Questionnaire.(48 months (plus 3 months))
- Behaviour assessed by the Strengths and Difficulties Questionnaire or it's subscales.(48 months (plus 3 months))
- Gestational age effect on the result of the developmental tests.(48 months (plus 3 months))