Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-29 @ 12:16 PM
Study NCT ID:
NCT05709392
Status:
RECRUITING
Last Update Posted:
2023-02-02
First Post:
2022-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
Sponsor:
Ostergotland County Council, Sweden
Organization:
Study Overview
Official Title:
Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PreDECESS
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?
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: