Involving parents in feeding premature infants in neonatal units
Impact of Parental Involvement in Enteral Nutrition on Their Presence in Neonatal Units
This study tests if letting parents help feed their premature babies in the NICU can improve bonding and feeding practices compared to using a feeding pump.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 3 Days and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 2 sites (Avignon and 1 other locations) |
| Trial ID | NCT05272956 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of parental involvement in enteral nutrition for premature infants by comparing two feeding methods: bolus feeding with a syringe under parental visual control versus enteral feeding with a syringe pump. The primary focus is on measuring parental presence in the neonatal unit during feeding sessions. The study aims to enhance parent-infant bonding and improve feeding practices in neonatal intensive care units (NICUs). It employs an open-label, randomized, comparative interventional design with an intention-to-treat analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants born between 30 and 34 weeks of gestation who are hospitalized in a neonatal intensive care unit.
Not a fit: Patients who are mechanically ventilated, have serious congenital malformations, or are unable to participate in feeding due to other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve parental bonding and involvement in the care of premature infants, potentially leading to better developmental outcomes.
How similar studies have performed: Previous studies in Sweden and France have explored parental involvement in feeding practices, but this study aims to provide definitive evidence on the superiority of the bolus feeding method under parental control.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age between 30 and 34 WA (weeks of amenorrhea) * Patient affiliated to a social security scheme * Hospitalized in neonatal intensive care unit (NICU) * 3 days of life or more Exclusion Criteria: Corrected age\> 34WA and 4 days * Mechanical ventilation or non-invasive ventilation with FIO2\> 35% * Serious congenital malformation * Planned transfer to another hospital * Enteral nutrition \<40ml / kg / day * Immediate post-operative care * Multiple pregnancy * Poor understanding of french • Secondary exclusion criteria * Digestive rest greater than 5 days * Death * No enteral nutrition pushed by parents
Where this trial is running
Avignon and 1 other locations
- Centre Hospitalier Henri Duffaut — Avignon, France (Recruiting)
- Limoges university hospital — Limoges, France (Recruiting)
Study contacts
- Study coordinator: Fabienne Mons, MD
- Email: fabienne.mons@chu-limoges.fr
- Phone: 555058666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.