Recent Updates
Recently added Catalysts

NIDCAP

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

NIDCAP · 1 trial · 2 indications

Early Phase 1 1
NCT00388141Nursing and Nurturing Premature InfantsInfant Growth
COMPLETED90 Analytics
EARLY_PHASE1COMPLETED
Nursing and Nurturing Premature Infants
Infant GrowthUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range7 Days to 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
Unlock Eligibility Criteria

Frequently asked questions about NIDCAP

What is NIDCAP used for?

NIDCAP is an investigational intervention being studied for infant growth and mothers' parental competence in premature infants. It is currently in early Phase 1 clinical development, meaning it is still being tested and is not yet approved for any use.

Who is developing NIDCAP?

NIDCAP is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the New York Stock Exchange under the ticker NVO. The company is conducting clinical research to evaluate the intervention's effects in premature infants.

What phase is NIDCAP in?

NIDCAP is in early Phase 1 clinical development. One clinical trial has been completed, and the intervention remains investigational. It has not been approved by regulatory authorities, and its safety and efficacy are still being evaluated.

What clinical trials is NIDCAP in?

NIDCAP has one completed clinical trial, NCT00388141, titled "Nursing and Nurturing Premature Infants." This trial enrolled 90 participants in Denmark and studied infant growth and mothers' parental competence in infants as young as 7 days old.

Is NIDCAP FDA approved?

NIDCAP is not FDA approved. It is an investigational intervention currently in early Phase 1 clinical development. The completed trial, NCT00388141, was an uncontrolled study, and further research is needed before any regulatory approval could be considered.