Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03320083
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2017-10-20
Brief Title:
Behavioral Insomnia of Childhood Impact of Parent Education
Sponsor:
Marmara University
Organization:
Marmara University
Study Overview
Official Title:
Associates and Natural Course of Behavioral Insomnia of Childhood Impact of Parent Education
Status:
COMPLETED
Status Verified Date:
2017-10
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:
None
Brief Summary:
Behavioral Insomnia of Childhood BIC is among the most prevalent problem presented to pediatricians with a reported occurrence of approximately 30 worldwideThe most widely applied treatment strategies for BIC in infants comprise behavioral procedures such as unmodified extinction graduated extinction ignoring the infant cries with minimal checks or camping out Unfortunately breastfeeding is usually considered as an undesirable sleep association in these strategies Moreover less is known regarding the effects of these interventions on breastfeeding outcomes The cued care is defined as a pattern of care characterized by sensible caregiver responsiveness which meets the need underlying the infants cues in a flexible manner In this context POSSUMS has been developed as a cued care sleep intervention which is quite different from the conventional sleep training techniques In the current study investigators hypothesized that mothers receiving the cued care sleep intervention would report less sleep problems in their infants Secondary outcomes included improvement in maternal mood and maintenance of the breastfeeding during the observation period
Detailed Description:
Behavioral Insomnia of Childhood BIC is among the most prevalent problem presented to pediatricians with a reported occurrence of approximately 30 worldwideLike all the other behavioral problems sleep problem is defined by the the parents and influenced by parental psychopathology parenting styles family dynamics culturally-based differences in values socio-economic factors temperament developmental stage and medical condition of the child Moreover there is also data suggesting an association of depressed mood among mothers to infants with BIC The most widely applied treatment strategies for BIC in infants comprise behavioral procedures such as unmodified extinction graduated extinction ignoring the infant cries with minimal checks or camping out The primary outcomes of these interventions include enabling infants to learn to self soothe to sleep having less fragmented night-time sleep and longer night-time sleep periods Unfortunately breastfeeding is usually considered as an undesirable sleep association in these strategies Moreover less is known regarding the effects of these interventions on breastfeeding outcomes Within the infant sleep research field not breastfed but the formula fed baby is usually considered as the biological norm However since nursing influences both the maternal and infant sleep architecture the outcomes of those behavioral interventions can not be accurately evaluated without considering the breastfeeding
The cued care is defined as a pattern of care characterized by sensible caregiver responsiveness which meets the need underlying the infants cues in a flexible manner In this context POSSUMS has been developed as a cued care sleep intervention which is quite different from the conventional sleep training techniques This method uses the breast to make the baby go back to sleep as quickly as possible as long as the mother is happy with breastfeeding at night
In the current study investigators hypothesized that mothers receiving the cued care sleep intervention would report less sleep problems in their infants Secondary outcomes included improvement in maternal mood and maintenance of the breastfeeding during the observation period
The first part of the study was a baseline assessment of sleep problems Software generated random number table was used to randomly allocate subjects to intervention and usual care groups Mother-infant dyads in both groups were reassessed 3 months post intervention
225 consecutive mother-infant dyads were assessed for eligibility at Marmara University Medical School well- child outpatient clinic Istanbul between 01 February 2016 and 15 April 2016 Seven did not meet the inclusion criteria and 35 participants declined to participate 91 were allocated to usual care and 92 were allocated to patient education Twenty five participants from the usual care and 1 mother infant dyad from the intervention group were lost to follow up and 157were included in the final analysis
The cued care is defined as a pattern of care characterized by sensible caregiver responsiveness which meets the need underlying the infants cues in a flexible manner In this context POSSUMS has been developed as a cued care sleep intervention which is quite different from the conventional sleep training techniques This method uses the breast to make the baby go back to sleep as quickly as possible as long as the mother is happy with breastfeeding at night
In the current study investigators hypothesized that mothers receiving the cued care sleep intervention would report less sleep problems in their infants Secondary outcomes included improvement in maternal mood and maintenance of the breastfeeding during the observation period
The first part of the study was a baseline assessment of sleep problems Software generated random number table was used to randomly allocate subjects to intervention and usual care groups Mother-infant dyads in both groups were reassessed 3 months post intervention
225 consecutive mother-infant dyads were assessed for eligibility at Marmara University Medical School well- child outpatient clinic Istanbul between 01 February 2016 and 15 April 2016 Seven did not meet the inclusion criteria and 35 participants declined to participate 91 were allocated to usual care and 92 were allocated to patient education Twenty five participants from the usual care and 1 mother infant dyad from the intervention group were lost to follow up and 157were included in the final analysis
Study Oversight
Has Oversight DMC:
None
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?:
None