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Fathers and Partners in Family Integrated Care Study

Recruitingn/aAges any - anyAllHomerton University Hospital NHS Foundation Trust
NCT06022991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

AIMS: The primary aim is to investigate the impact of enhancing father/partner engagement in FICare of preterm infants on their mental health (MH) up to 6 weeks post discharge. Secondary aims are to investigate the impact on maternal MH. METHOD and ANALYSIS: This is a two-phase study: Phase-1 to gather baseline information and Phase-2 to assess the impact of improved father/partner engagement in FICare involving two NUs (a tertiary and level 2). 20 families of infants born at \<33 weeks will be studied in each phase (40 fathers, 40 mothers, 40 babies). Father/partner MH will be assessed using validated questionnaires: Generalised Anxiety Disorder Assessment (GAD-7), Patient Health Questionnaire (PHQ-9), Parental Stressor Scale: NICU (PSS:NICU), and by semi-structured qualitative interviews. Similarly, mothers will be assessed by the same questionnaires and focus groups. The Neonatal D

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📋 Eligibility rules (as published)
Parents of preterm infants will be recruited to the study. Inclusion criteria: 1. Parents of 22+0 to 32+6 weeks preterm infants. 2. Infant from day one to 7 days of age. 3. Infant should have two primary caregivers. Father's/Partner's participation in the study is a must and participation from both parents is ideal. 4. The parents should have conversational English. Exclusion criteria: 1. Infant with life-limiting condition or no realistic chance of survival. 2. Infant is likely to be transferred to non-participating centre within 4 weeks of age. 3. Parents under the age of 16 years.
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What it tests

  • Not listed
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Where

2 sites
Neonatal Unit, Whipps Cross University Hospital
London, United Kingdom
Neonatal Unit, Homerton University Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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