Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Bonding
研究概览
简要总结
The PreDECESS trial is a prospective study where that will evaluate a new method taking care of premature infants in gestational weeks 30+0 to 34+6 at birth. The new method includes delayed cord clamping and early skin-to-skin contact with a parent. Two populations of infants with their parents will be compared. Infants taken care of in the traditional way before the new method is introduced, and infants taken care of with the new method when it is being introduced.
Primary question:
Does delayed cord clamping and early skin-to skin contact (SSC) lead to better bonding between parents and their infants?
Secondary questions:
Are there any potential adverse effects with delayed cord clamping and early skin-to skin contact (SSC)? Is there a difference in infants level of bilirubin, haemoglobin or proBNP? Is there a difference in infants growth? Is there a difference in infants neurological development? Is there a difference in infants and parents level of stress? Is there a difference in mothers production of breastmilk, frequency of breastfeeding or experience of breastfeeding? Is there a difference in parents mood? How do parents of preterm infants experience giving birth of their preterm baby before and after the introduction of the new method?
详细描述
A new method taking care of premature infants at birth is going to be introduced in several hospitals in Sweden. The new method includes delayed cord clamping (> 3 minutes) and early skin-to-skin contact with a parent. If the infant needs help with the breathing this can be given during the time when the cord is still intact. This method is different from the traditionally way used for the moment when the the cord is clamped soon after the infant is born and bring the infant to a resuscitation table, often outside the delivery room, to stabilize the infant, for example with support for the breathing with ventilation, CPAP (Continuous Positive Airway Pressure) or intubation.
The PreDECESS trial will study how this delayed cord clamping and skin-to-skin contact will affect the infants and their parents.
The study will have a cohort of premature infants taken care of at birth in the traditional way and another cohort of infants taken care of with the new method. The study will be prospective and the control group will be enrolled first and the active group after the new method has been introduced. It will be multi-center study and hospitals in Linköping, Norrköping, Kalmar, Lund and Huddinge will participate. Infants born in gestational weeks 30+0-34+6 through vaginal delivery and admitted to neonatal ward in Sweden will be included.
The trial is going to study bonding with Swedish Mother-to-Infant Bonding Scale (S-MIBS) and Postpartum Bonding Questionnaire (PBQ). Both parents will also fill in questionnaires for evaluation of depression which might have an impact on bonding, Edinburgh Postpartum Depression Scale (EPDS). There might be connections between bonding and breast-feeding and for that analysis we will use Breastfeeding Self efficacy scale (BSES-SF), a questionary which mothers will answer. The infant's neurological development will be evaluated with a questionary to parents, Ages and Stages Questionnaires (ASQ-3). Infants and parents stress will be measured with cortisol and oxytocin in saliva. The infant's temperature, heart frequency, oxygen saturation, oxygen level and need of respiratory assistance for the first three hours after they are born will be documented. Blood sugar, haemoglobin and bilirubin will be taken as part of the clinical practice. ProBNP will be taken when other laboratory parameters are taken as an indicator of heart function. Residual blood in the placenta after cord clamping will be measured. Data from the neonatal period will be collected from the Swedish Quality Register (www.snq.se), and maternal data will be collected from the Swedish Pregnancy Register (www.graviditetsregistret.se).
A validation of the Swedish Mother-to-Infant Bonding Scale (S-MIBS) will be a part of the trial since this has not been done on premature infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born in gestational weeks 30+0-34+6 through vaginal delivery and admitted to neonatal ward in Sweden.
- •Parents must be able to read Swedish.
排除标准
- •Infants with known disease when an expanded blood volume is expected will be excluded as early cord clamping is recommended (severe anemia, cardiac disease etc).
- •Infants with known malformations. Infants with severe or moderate asphyxia (defined as APGAR < 4 at 5 minutes of age).
- •Infants where the physician in charge find it inappropriate with delayed cord clamping.
- •No time for cord clamping has been registered.
结局指标
主要结局
Bonding
时间窗: Parents will answer the questionnaires when the infants are 6 months old corrected age.
Bonding will be assessed with self a administrative instrument, Mother-to-Infant Bonding Scale (S-MIBS), to parents.It consists of eight adjectives, each describing an emotion and parents will answer how well the adjectives correlated to how they felt for the last 7 days on a four-point scale ranging from 0 to 3. The maximum score is 24, with higher values indicating more bonding challenges.
次要结局
- Heart frequency,(The heart frequency will be registered on a documental sheet when the infants are 10, 20, 30, 60, 90, 120, 150 and 180 minutes old. This will be done with all vaginal deliveries as long as the study is going on.)
- Respiratory frequency(The respiratory frequency will be registered on a documental sheet when the infants are 10, 20, 30, 60, 90, 120, 150 and 180 minutes old. This will be done with all vaginal deliveries as long as the study is going on.)
- Oxygen saturation(Oxygen saturation will be registered on a documental sheet when the infants are 10, 20, 30, 60, 90, 120, 150 and 180 minutes old.This will be done with all vaginal deliveries as long as the study is going on.)
- Necrotising enterocolitis, NEC(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Cortisol in saliva(The saliva tests will be done when the infants are 7 ± 1 days, and 1 month corrected age.)
- Oxytocin in saliva(The oxytocin tests will be taken when the infants are 8 ± 1 days old.)
- Depression in parents(Parents will answer the questionnaire 1 week and 1 month after delivery and when the infants are 2 and 6 months old corrected age.)
- Experience of breastfeeding(Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age.)
- Breastmilk production(Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age. Data from the Swedish Quality Register will be collected after all the infants have been included in the study.)
- Respiratory support(Possible need and what kind of respiratory support will be registered on a documental sheet for the first 3 hours after delivery. This will be done with all vaginal deliveries as long as the study is going on.)
- Oxygen level(Possible need of extra oxygen will be registered on a documental sheet for the first 3 hours after delivery.This will be done with all vaginal deliveries as long as the study is going on.)
- Spontaneous intestinal perforation, SIP(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Surgery(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Sepsis(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Suspected sepsis(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Frequency of breastfeeding(Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age. Data from the Swedish Quality Register will be collected after all the infants have been included in the study.)
- Ventilation(Possible need of ventilation will be registered on a documental sheet in the delivery room until discharge from the hospital, up to 1 month corrected age. This will be done with all vaginal deliveries as long as the study is going on.)
- Blood sugar(Tests will be taken as part of the clinical routine and registered on the same documental sheet as all other outcomes described above until discharge from the hospital, up to 1 month corrected age.)
- Bilirubin(Tests will be taken as part of the clinical routine and registered on the same documental sheet as all other outcomes described above until discharge from the hospital, up to 1 month corrected age.)
- Haemoglobin(Tests will be taken as part of the clinical routine and registered on the same documental sheet as all other outcomes described until discharge from the hospital, up to 1 month corrected age.)
- ProBNP(ProBNP will be taken at the same time as PKU, when the infants are between 48 and 72 hours old. This will be done with all vaginal deliveries as long as the study is going on.)
- Childrens growth in weight(Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age. Data from the Swedish Quality Register will be collected after all the infants have been included in the study.)
- Childrens growth in length(Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age. Data from the Swedish Quality Register will be collected after all the infants have been included in the study.)
- Childrens growth in head circumference(Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age. Data from the Swedish Quality Register will be collected after all the infants have been included in the study.)
- Childrens neurological development(Parents will answer the questionnaires when the infants are 12 and 48 months old corrected age.)
- Residual blood in placenta(Residual blood will be measured directly after each delivery and registered on a documentation sheet. This will be done with all vaginal deliveries as long as the study is going on.)
- Temperature(The temperature will be registered on a documental sheet when the infants are 20, 60, 120 and 180 minutes old. This will be done with all vaginal deliveries as long as the study is going on.)
- Pneumonia(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Respiratory distress syndrome, RDS(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Bronchopulmonary dysplasia, BPD(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Interstitial emphysema(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Pneumothorax(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Neonatal adaption syndrome, NAS(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Pulmonary adaption disorder, PAS(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Retinopathy of the prematurity, ROP(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Intraventricular haemorrhage, IVH(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Periventricular leukomalacia, PVL(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Seizures(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Persistent ductus arteriosus(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Number of days with intensive care(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Length of stay at the hospital(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Mortality(Data will be collected from the Swedish Quality Register after all the infants have been included in the study, approximately between 1 and 8 years from study start.)
- Parents experiences(Parents will be interviewed close to discharge from hospital or when their children are still in neonatal home care, up to 3 months corrected age. This will be as long as the study is going on.)
研究者
Thomas Abrahamsson, MD, PhD
Associate Professor
Ostergotland County Council, Sweden