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NIDCAP · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| NIDCAP | EXPERIMENTAL | In 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 |
| Name | Type | Description |
|---|---|---|
| NIDCAP | BEHAVIORAL | Systematic 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 |
Inclusion Criteria: * Premature infants * The infants' biological mothers Exclusion Criteria: * Premature infants with chromosomal anomaly * Mothers who cannot read and understand Danish
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.
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.
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.
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.
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.