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NIDCAP

Phase 1

Infant Growth | Unknown | Other |Novo Nordisk A/S|Last Updated: Dec 3, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00388141Nursing and Nurturing Premature InfantsEARLY_PHASE1 COMPLETED 90Mar 1, 2005Jun 1, 2007Dec 3, 20071 Denmark
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Study Endpoints
Primary Endpoints
The mothers' self reported experiences of self esteem and social support
18 months
Secondary Endpoints
Infant growth
18 months
Time of discharge
18 months
Days of needing oxygen and respiratory support
18 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeSUPPORTIVE_CARE
Treatment Arms
ArmTypeDescription
NIDCAPEXPERIMENTALIn the intervention NIDCAP group the staff has been introduced and trained in the principles of the NIDCAP-care, where main core is to see, organize and conduct the care of the preterm infant on behalf of the childs actually resources and competences
Interventions
NameTypeDescription
NIDCAPBEHAVIORALSystematic care, where the mother and the nurses organize the caring on behalf of the preterm infants' ressources and developmental capacity such as the infant avoid over stimulation and distress
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Eligibility Criteria
Age Range7 Days — 32 Weeks
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Premature infants * The infants' biological mothers Exclusion Criteria: * Premature infants with chromosomal anomaly * Mothers who cannot read and understand Danish

Countries:Denmark
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