Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-34
SponsorOstergotland County Council, Sweden
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
Delayed cord clamping and early skin-to-skin contact
Procedure/SurgeryA new method for taking care of remature infants born in gestational weeks 30+0-34+6 will be introduced with delayed cord clamping 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Parents will answer the questionnaires 1 week after delivery.2
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.
Time frame
Parents will answer the questionnaires 1 week after delivery.3
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.
Time frame
Parents will answer the questionnaires 1 month after delivery.4
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.
Time frame
Parents will answer the questionnaires 1 month after delivery.Secondary outcomes
1
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.
Time frame
The saliva tests will be done when the infants are 7 ± 1 days, and 1 month corrected age.2
Oxytocin in saliva
Oxytocin in saliva will be taken on infants and their mothers before, during and after skin-to-skin holding.
Time frame
The oxytocin tests will be taken when the infants are 8 ± 1 days old.3
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.
Time frame
Parents will answer the questionnaire 1 week and 1 month after delivery and when the infants are 2 and 6 months old corrected age.4
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.
Time frame
Mothers will answer the questionnaire when the infants are 2 and 6 months old corrected age.Sponsors and contacts
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Source ClinicalTrials.gov