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Clinical Trials/ISRCTN36848750
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.

Registry
who.int
Start Date
January 21, 2013
End Date
May 31, 2016
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Oxford (UK)

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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