Clinical trial NCT05709392: Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
Official title: Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bonding
Stress
Breastfeeding
Child Development
Adverse Events
Keywords: adverse events
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 126
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Comparison of a cohort of premature infants born in gestational week 30+0 till 34+6 taken care of at birth in the traditional way and another cohort of infants taken care of with a new method. The study will be prospective and the control group will be enrolled first before and the active group after the new method has been introduced.
Primary purpose: TREATMENT

Brief summary: 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?

Detailed description: 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.

A qualitative study where we will interview parents to explore their experiences with premature birth, will also be part of the trial. Parents from both epochs, before and after introduction of the new method, will be asked to be included in the sub study. This qualitative part will be done in the hospitals in Linköping and Norrköping.

Cortisol and oxytocin in saliva before and after the introduction of the new method will be analysed as stress markers.

At least 63 infants in the controlgroup has to be included. This makes it possible to analyse two of our most important questions. The first is hypothermia that is a risk factor with the new method. Thermal control has previously been documented as a cornerstone in a study with immediate skin-to skin contact with parents for premature infants born in gestational weeks 28+0 to 31+6. The second important question is the validation of the Swedish Mother-to-Infant Bonding Scale(S-MIBS). After 63 mothers in the controlgroup have answered S-MIBS we will do an interim analysis to decide the final number participants needed in the trial. If the differences are small between the control group in our study and the suspected outcome in the active group (assumed from normal material previously described in a study where S-MIBS were validated on mothers to healthy fullborn infants by our research group), there will be needed very many infants to prove differences between the two groups. Therefore the study has an upper limit set on 6 months as time for inclusion of the control group at every study site. However, the inclusion will continue until at least 126 infants have been included, ie the inclusion time could be longer than 6 months in that situation.

Intention to treat analyses will be applied. Per protocol analyses will also be done including only infants and mothers in each study group that have followed the study protocol. In the control group mothers should not have skin-to-skin contact with the infants for more than 5 minutes during the first 10 minutes and more than 30 minutes for the first 2 hours to participate in the per protocol analysis. The same applies to the infants, but for some safety analyses there must also not have been delayed cord clamping (\> 3 minutes). In the interventiongroup mothers and/or partners should have skin-to-skin contact with the infant all the time except when procedures like resuscitation or insertion of an intravenous line has to be done. The infant should have delayed cord clamping according to the criteria. Sensitivity tests of intention to treat analyses can be done with help from the per protocol analyses.

Descriptive statistics will be used for all quantitative outcome measures: mean ± standard deviation and median ± interquartile range. For qualitative outcome measures proportions and/either percent will be used.

For both primary and secondary outcomes Chi2 test (or Fisher´s exact test if any suspected value is less than 5 )will be used to calculate dichotomous values, t-test to calculate continous data which are normally distributed and Mann-Whitney U test for not normally distributed data. For correlation analysis Pearson and Spearman will be used. Regression models (multiple linear, Cox proportional hazards depending on sort of data) will be used to adjust for potential confounders like gestational week, birth wight, gender, APGAR-score and study site. Relative effect of the intervention will be describes with 95% confidence intervals. All analysis will be given account with two-sides 5 % level of significance.

Approval by the Swedish Ethical Review Authority have been obtained for the trial (Dnr 2022-01611-01).

Eligibility criteria: 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.

Primary outcomes:
measure: Bonding
timeFrame: Parents will answer the questionnaires 1 week after delivery.
measure: Bonding
timeFrame: Parents will answer the questionnaires 1 week after delivery.
measure: Bonding
timeFrame: Parents will answer the questionnaires 1 month after delivery.
measure: Bonding
timeFrame: Parents will answer the questionnaires 1 month after delivery.
measure: Bonding
timeFrame: Parents will answer the questionnaires when the infants are 2 months old corrected age.
measure: Bonding
timeFrame: Parents will answer the questionnaires when the infants are 2 months old corrected age.
measure: Bonding
timeFrame: Parents will answer the questionnaires when the infants are 6 months old corrected age.
measure: Bonding
timeFrame: Parents will answer the questionnaires when the infants are 6 months old corrected age.
Secondary outcomes:
measure: Cortisol in saliva
timeFrame: The saliva tests will be done when the infants are 7 ± 1 days, and 1 month corrected age.
measure: Oxytocin in saliva
timeFrame: The oxytocin tests will be taken when the infants are 8 ± 1 days old.
measure: Depression in parents
timeFrame: Parents will answer the questionnaire 1 week and 1 month after delivery and when the infants are 2 and 6 months old corrected age.
measure: Experience of breastfeeding
timeFrame: Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age.
measure: Breastmilk production
timeFrame: 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.
measure: Frequency of breastfeeding
timeFrame: 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.
measure: Childrens growth in weight
timeFrame: 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.
measure: Childrens growth in length
timeFrame: 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.
measure: Childrens growth in head circumference
timeFrame: 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.
measure: Childrens neurological development
timeFrame: Parents will answer the questionnaires when the infants are 12 and 48 months old corrected age.
measure: Residual blood in placenta
timeFrame: 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.
measure: Temperature
timeFrame: 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.
measure: Heart frequency,
timeFrame: 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.
measure: Respiratory frequency
timeFrame: 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.
measure: Oxygen saturation
timeFrame: 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.
measure: Respiratory support
timeFrame: 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.
measure: Oxygen level
timeFrame: 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.
measure: Ventilation
timeFrame: 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.
measure: Blood sugar
timeFrame: 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.
measure: Bilirubin
timeFrame: 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.
measure: Haemoglobin
timeFrame: 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.
measure: ProBNP
timeFrame: 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.
measure: Necrotising enterocolitis, NEC
timeFrame: 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.
measure: Spontaneous intestinal perforation, SIP
timeFrame: 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.
measure: Surgery
timeFrame: 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.
measure: Sepsis
timeFrame: 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.
measure: Suspected sepsis
timeFrame: 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.
measure: Pneumonia
timeFrame: 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.
measure: Respiratory distress syndrome, RDS
timeFrame: 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.
measure: Bronchopulmonary dysplasia, BPD
timeFrame: 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.
measure: Interstitial emphysema
timeFrame: 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.
measure: Pneumothorax
timeFrame: 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.
measure: Neonatal adaption syndrome, NAS
timeFrame: 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.
measure: Pulmonary adaption disorder, PAS
timeFrame: 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.
measure: Retinopathy of the prematurity, ROP
timeFrame: 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.
measure: Intraventricular haemorrhage, IVH
timeFrame: 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.
measure: Periventricular leukomalacia, PVL
timeFrame: 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.
measure: Seizures
timeFrame: 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.
measure: Persistent ductus arteriosus
timeFrame: 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.
measure: Number of days with intensive care
timeFrame: 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.
measure: Length of stay at the hospital
timeFrame: 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.
measure: Mortality
timeFrame: 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.
measure: Parents experiences
timeFrame: 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.
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Crown Princess Victoria children´s hopsital
Study officials:
References: