Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: parent-pushed enteral feeding, syringe-push enteral feeding.
- Who it may be relevant to
- Registry conditions: Premature, Parent-Child Relations. Basic parameters: 30 Weeks — 32 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)
Overview
Studies underline both the importance of the link and contact that occurs in the earliest days of life and the need to involve parents early with their premature child. However, the impact of parental nutrition on the later active nutrition and on the quality of parent-child interactions is currently unknown. PREMIAM study investigates whether active parental participation in enteral nutrition improves the interactions between the infant and his parents, making them more sensitive to their baby's signals and promoting their relational adjustment.
Detailed description
The importance of parental participation in the feeding of preterm infants has been highlighted by Gianni. In his study of 81 preterm infants in the tertiary centre , the early parental bottle feeding and the skin-to-skin contact were factors promoting withdrawal from enteral nutrition. Moreover, actively participate in care even complex, is desired by parents.
Recently, a study compared 10 parent-child dyads and showed that enteral nutrition pushed by a parent (parental nutrition, NP) in comparison of the electric syringe pump , allowed a better perception of the tube by the parents and gave them a sense of utility. The same team randomized 17 preterm infants, born after 28 WA( week amenorrhoea), to receive or not à parent-pushed enteral nutrition The child's behavior changes during nutrition were analyzed in both arms, after scoring of the videos feeding according to the NICAP® ( individualized neonatal assessment and developmental care program) method. Signs of well-being and relaxation of members were more present in case of parental involvement in the delivery of nutrition. These preliminary studies suggest that parental nutrition is well tolerated and improves the comfort of the child and parent during nutrition.
However, the impact of parental nutrition on the subsequent active nutrition and on the quality of parent-child interactions is currently unknown.
Interventions
- Other parent-pushed enteral feeding
skin-to-skin enteral nutrition pushed by the parent - Other syringe-push enteral feeding
skin to skin nutrition with syringe pump
Primary outcome measures
- behavioural interactions (visual, vocal, mimic) [Time frame: 34 (W) weeks of gestational age]
Secondary outcome measures (12)
- Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS) [Time frame: at Month 4]
- Edinburgh Postpartum Depression Risk Rating Scale (EPDS) [Time frame: at inclusion, at 32, 34 and 37 weeks of gestation]
- Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU) [Time frame: at 32, 34, and 37 weeks of gestation]
- Number of desaturation [Time frame: every day betwenn 32 and 34 weeks of gestation]
- Number of vomiting [Time frame: every day between 32 and 34 weeks of gestation]
- Exit age on return home [Time frame: through study completion, an average of 41 week of gestation]
- Parental time in hours [Time frame: at 34 week of gestation and 37 week of gestation, calculated over 7 days]
- Number of meals and baths given by parents [Time frame: from 32 week of gestation to 37 week of gestation]
- Duration of transition from passive to active feeding in number of days [Time frame: from 32 week of gestation to 37 week of gestation]
- Average duration (minutes) of feeding/feeding [Time frame: at 37 week of gestation]
- Number and duration of skin-to-skin sessions in minutes [Time frame: from inclusion to exit of service ( up to 45 week of gestation)]
- Duration of breastfeeding in number of days. [Time frame: from 32 week of gestation to 37 week of gestation]
Eligibility criteria
Inclusion criteria
Children born before 30 SA Age of child at start of study: 32 SA
Exclusion criteria
- Child with ongoing infection, neurological pathology More than one desaturation and/or bradycardia per hour within 12 last hours Balloon ventilation in last 12 hours
- Medical contraindication to oral nutrition
- Intubated child
- Parents with a disabling mental illness
- Parents not available
- Minor parents
- Parents under guardianship or protection of justice
- Refusal to sign consent
- Parents not affiliated with a social security system
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Hospitalier Intercommunal Créteil — Créteil
Identifiers
NCT: NCT05313464 · PREMIAM