Stress Clinical Trial
— PreDECESSOfficial title:
Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact
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?
Status | Recruiting |
Enrollment | 126 |
Est. completion date | December 11, 2028 |
Est. primary completion date | December 11, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Weeks to 34 Weeks |
Eligibility | Inclusion Criteria: 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. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Crown Princess Victoria children´s hopsital | Linkoping |
Lead Sponsor | Collaborator |
---|---|
Ostergotland County Council, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bonding | Bonding will be assessed with a self 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. | Parents will answer the questionnaires 1 week after delivery. | |
Primary | Bonding | Bonding will be assessed with a self administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. ]. It consists of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems. | Parents will answer the questionnaires 1 week after delivery. | |
Primary | Bonding | Bonding will be assessed with a self 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. | Parents will answer the questionnaires 1 month after delivery. | |
Primary | Bonding | Bonding will be assessed with a self administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. It consist of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems. | Parents will answer the questionnaires 1 month after delivery. | |
Primary | Bonding | Bonding will be assessed with a self 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. | Parents will answer the questionnaires when the infants are 2 months old corrected age. | |
Primary | Bonding | Bonding will be assessed with a self administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. It consists of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems. | Parents will answer the questionnaires when the infants are 2 months old corrected age. | |
Primary | Bonding | 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. | Parents will answer the questionnaires when the infants are 6 months old corrected age. | |
Primary | Bonding | Bonding will be assessed with self a administrative instrument, Postpartum Bonding Questionnaire (PBQ), to parents. It consists of 25 statements about parents feelings, where parents answer how well statement applies to them on a six-point scales ranging from 0 to 5, with higher values indicating more problems. | Parents will answer the questionnaires when the infants are 6 months old corrected age. | |
Secondary | Cortisol in saliva | Cortisol in saliva will be taken on infants before and after diaper change. Cortisol in saliva is measured on both parents at the same time. | The saliva tests will be done when the infants are 7 ± 1 days, and 1 month corrected age. | |
Secondary | Oxytocin in saliva | Oxytocin in saliva will be taken on infants and their mothers before, during and after skin-to-skin holding. | The oxytocin tests will be taken when the infants are 8 ± 1 days old. | |
Secondary | Depression in parents | Depression will be assessed with a self administrative instrument, Edinburgh Postnatal Depression Scale (EPDS), to parents. It consists of 10 questions rated on a scale ranging from 0 to 3, with higher values indicating more symptoms. | Parents will answer the questionnaire 1 week and 1 month after delivery and when the infants are 2 and 6 months old corrected age. | |
Secondary | Experience of breastfeeding | Mothers experiences of breastfeeding will be evaluated with a self administrative instrument, Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), to mothers. It assess breast-feeding confidence and consists of 33 items scored on a 5-point scale ranging from 1 (not at all confident) to 5 (always confident). As such, total scores can range from 33 to 165, with higher scores reflecting greater levels of breastfeeding self-efficacy. | Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age. | |
Secondary | Breastmilk production | Mothers breastmilk production will be assessed with an extra question on the questionnaire Breastfeeding Self-Efficacy Scale-Short Form where the mothers will answer what kind of food their infants are eating, mothers own breastmilk or formula, and approximately how big part of each. Data will also be taken from the Swedish Quality Register where it will be registered what kind of food the infants are eating when they are discharged from hospital. | 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. | |
Secondary | Frequency of breastfeeding | Mothers frequency of breastfeeding will be assessed with an extra question on the questionnaire Breastfeeding Self-Efficacy Scale-Short Form where the mothers will answer if they are breastfeeding their babies, totally or partly and if party approximately how much. Data will also be taken from the Swedish Quality Register where it will be registered if mothers are breastfeeding when the infants are discharged from hospital, totally or partly. | 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. | |
Secondary | Childrens growth in weight | How the children grows will be assessed with an extra question on the questionnaire Breastfeeding Self-Efficacy Scale-Short Form where mothers will answer what the infants weight, length and head circumference was at their latest visit at BVC. Data will also be taken from the Swedish Quality Register where the infants weight, length and circumference at discharge fron hospital will be registered. | 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. | |
Secondary | Childrens growth in length | How the children grows will be assessed with an extra question on the questionnaire Breastfeeding Self-Efficacy Scale-Short Form where mothers will answer what the infants weight, length and head circumference was at their latest visit at BVC. Data will also be taken from the Swedish Quality Register where the infants weight, length and circumference at discharge fron hospital will be registered. | 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. | |
Secondary | Childrens growth in head circumference | How the children grows will be assessed with an extra question on the questionnaire Breastfeeding Self-Efficacy Scale-Short Form where mothers will answer what the infants weight, length and head circumference was at their latest visit at BVC. Data will also be taken from the Swedish Quality Register where the infants weight, length and circumference at discharge fron hospital will be registered. | 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. | |
Secondary | Childrens neurological development | Neurological development will be assessed with a self administrative instrument, Ages and Stages Questionnaires (ASQ-3) to parents. It is a developmental screening tool that pinpoints developmental progress in children. It covers five areas of child development that includes: communication, gross motor, fine motor, problem solving, personal-social. There are scores for each area: Yes = 10 points, sometimes = 5 points, not yet = 0 points. Total scores are calculated and higher scores indicate more positive outcomes. | Parents will answer the questionnaires when the infants are 12 and 48 months old corrected age. | |
Secondary | Residual blood in placenta | Residual amount of blood in placenta after cord clamping will be measured by allowing the blood that is left after the placenta transfusion flow passively out i a bowl. | 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. | |
Secondary | Temperature | Infants temperature will be measured regularly during the first 3 hours after delivery. Number of infants with temperature < 36,5 will be documented in the report. | 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. | |
Secondary | Heart frequency, | Infants heart frequency will be measured regularly during the first 3 hours after delivery. | 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. | |
Secondary | Respiratory frequency | Infants respiratory frequency will be measured regularly during the first 3 hours after delivery. | 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. | |
Secondary | Oxygen saturation | Infants oxygen saturation will be measured regularly during the first 3 hours after delivery. Saturation in percent between 0 and 100 will be registered. Number of infants with saturation < 90 percent will be documented in the report. | 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. | |
Secondary | Respiratory support | Infants need of respiratory support during the first 3 hour after delivery. | 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. | |
Secondary | Oxygen level | Infants need of extra oxygen during the first 3 hour after delivery. Fraction of inspired Oxygen (FiO2) will be registered. | 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. | |
Secondary | Ventilation | Infants need of ventilation in the delivery room. | 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. | |
Secondary | Blood sugar | Infants blood sugar will be measured as part of the clinical routine. Hypoglycemia is defined as blood sugar < 2,6. | 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. | |
Secondary | Bilirubin | Bilirubin level will be measured on the skin or in the blood as part of the clinical routine. | 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. | |
Secondary | Haemoglobin | Blood haemoglobin level will be measured as part of the clinical routine. | 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. | |
Secondary | ProBNP | ProBNP in blood will be measured to assess heart function. The test will be taken as part of the clinical routine at the same time as the PKU test which is taken on all babies in Sweden. | 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. | |
Secondary | Necrotising enterocolitis, NEC | Diagnosed clinical, radiological or with autopsy. Incidens in both study groups will be reported. | 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. | |
Secondary | Spontaneous intestinal perforation, SIP | Focal intestinal perforation. Diagnosed with operation or autopsy. Incidens in both study groups will be reported. | 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. | |
Secondary | Surgery | Extensive surgery in the abdomen, thorax or head. Surgery that is reported according to clinical routines in the Swedish Quality Register. Incidens in both study groups will be reported. | 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. | |
Secondary | Sepsis | Clinical symptoms och =1 positive blood culture and laboratory signs of infection according to the clinical routines. Incidens in both study groups will be reported. | 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. | |
Secondary | Suspected sepsis | Clinical symptoms and laboratory signs of infection, but not culture-proven. Incidens in both study groups will be reported. | 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. | |
Secondary | Pneumonia | Pathological X-ray confirmed, need of increased respiratory support/oxygen and laboratory inflammatory response.Incidens in both study groups will be reported. | 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. | |
Secondary | Respiratory distress syndrome, RDS | paO2 <6,6 kPa or central cyanosis in air or need of extra oxygen to reach paO2 =6.6 and RDS on chest X-ray. Incidens in both study groups will be reported. | 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. | |
Secondary | Bronchopulmonary dysplasia, BPD | Diagnose according to clinical routines, usually meaning need of extra oxygen in gestational week 36+0. Incidens in both study groups will be reported. | 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. | |
Secondary | Interstitial emphysema | Diagnose on chest X-ray. Incidens in both study groups will be reported. | 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. | |
Secondary | Pneumothorax | Pneumothorax, meaning air in the pleural space, that needs to be drained. Incidens in both study groups will be reported. | 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. | |
Secondary | Neonatal adaption syndrome, NAS | The mildest form of respiratory disorder with laboured breathing. Incidens in both study groups will be reported. | 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. | |
Secondary | Pulmonary adaption disorder, PAS | A slightly more pronounced form of respiratory disorder with the same symptoms , but persists longer and with signs of fluid in the lungs on X-ray. Incidens in both study groups will be reported. | 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. | |
Secondary | Retinopathy of the prematurity, ROP | Diagnosed by an independent ophthalmologist according to international classification. Incidens in both study groups will be reported. | 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. | |
Secondary | Intraventricular haemorrhage, IVH | Diagnosed according to international classification. Incidens in both study groups will be reported. | 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. | |
Secondary | Periventricular leukomalacia, PVL | Diagnosed according to international classification. Only cystic periventricular leukomalacia will be registered. Incidens in both study groups will be reported. | 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. | |
Secondary | Seizures | Multiple seizures during the first 12 hours. Clinical or on EEG. Incidens in both study groups will be reported. | 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. | |
Secondary | Persistent ductus arteriosus | Persistent ductus arteriosus treated with medicine or surgery. Incidens in both study groups will be reported. | 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. | |
Secondary | Number of days with intensive care | Need of respirator or CPAP until discharge (not later than gestational week 44+0). | 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. | |
Secondary | Length of stay at the hospital | Gestational week and day at discharge (not later than gestational week 44+0). | 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. | |
Secondary | Mortality | Including cause of death. Incidens in both study groups will be reported. | 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. | |
Secondary | Parents experiences | To explore parents' experiences in relation to birth of their preterm baby when delayed cord clamping and early skin-to-skin contact is practiced parents from both epochs will be interviewed. | 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. |
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