ISRCTN36848750
Completed
未知
Improving Cognitive Outcomes of Children with Cleft Lip and/or Palate: a randomised controlled trial aimed at enhancing the quality of mother-infant interactions
niversity of Oxford (UK)0 sites80 target enrollmentJanuary 21, 2013
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cleft lip and palate
- Sponsor
- niversity of Oxford (UK)
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Mother is willing and able to give informed consent for participation in the study
- •2\. Mother, aged 18 years or above
- •3\. Infant diagnosed with cleft lip with/without cleft palate
- •4\. Able (in the Investigators' opinion) and willing to comply with all study requirements
- •5\. Infant born at \> 35 weeks gestation
- •6\. Infant birth weight of \> 2000 grams
- •7\. Mother willing to allow her and her infant?s General Practitioner and cleft Consultant to be notified of participation in the study
Exclusion Criteria
- •1\. Life\-threatening or other serious physical illness in the mother
- •2\. Serious illness or medical complication in the infant
- •3\. Infant in Child Protection Plan (child protection register)
- •4\. Mother unable to converse in English
- •5\. Mother not primary caregiver to infant
- •6\. Mother has severe psychiatric diagnosis
- •7\. Mother and infant live outwith 90 minutes travel of research centre
Outcomes
Primary Outcomes
Not specified
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