Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions (PREMIAM)

Effect of Parental Enteral Nutrition on Quality Of Parent-Child Interactions: Prospective Randomized Monocentric Study (PREMIAM)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parent-Child Relations; Premature
• Intervention / Treatment: Other: parent-pushed enteral feeding; Other: syringe-push enteral feeding

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nelly THOMAS; Phone Number: +33 01.57.02.34.62; Email: nelly.thomas@chicreteil.fr
• Study Contact Backup: Name: Camille Jung; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Val-deMarne
    • Créteil, Val-deMarne, France, 94000
      • Centre Hospitalier Intercommunal Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nutrition pushed by parents; enteral nutrition pushed by parents	Other: parent-pushed enteral feeding; skin-to-skin enteral nutrition pushed by the parent
Active Comparator: syringe pump; Enteral nutrition with syringe pump	Other: syringe-push enteral feeding; skin to skin nutrition with syringe pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
behavioural interactions (visual, vocal, mimic)	interactions during the first 10 minutes of an interactive sequence of a premature in the arms of his parent, filmed and coded with The Observer XT software to 34 WA, starting from 3 behaviors of the premature: vocalization, face look mother" and smile	34 (W) weeks of gestational age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother and Father Self-Question Assessment of Parental Competence: The Cognitive and Parental Behaviour Scale (PACOTIS)	Parents indicate on an eleven point scale (0 = not at all what I think, feel, or do; 10 = exactly what I think, feel, or do) to what extent each statement accurately describes their actions, thoughts or feelings in the context of interacting with their infants. The parental self-efficacy (6 items, α = .82), and perceived parental impact (5 items, α = .68) subscales include statements relating to beliefs about parenting competence and their impact on the child, while the parental hostile-reactive behaviours (7 items, α = .73), parental overprotection (5 items, α = .60), and parental warmth (5 items, α= .78) subscales assess parents' involvement in different types of behaviour with their child. Scores from each subscale are averaged out of 10; higher scores indicating greater use of these behaviours. the Perceived parental impact subscale items are reverse coded.	at Month 4
Edinburgh Postpartum Depression Risk Rating Scale (EPDS)	Questionnaire EPSD QUESTIONS 1, 2, & 4 (without an *) Are scored 0, 1, 2 or 3 with top box scored as 0 and the bottom box scored as 3. QUESTIONS 3, 5-10 (marked with an *) Are reverse scored, with the top box scored as a 3 and the bottom box scored as 0. Maximum score: 30 Possible Depression: 10 or greater Always look at item 10 (suicidal thoughts)	at inclusion, at 32, 34 and 37 weeks of gestation
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)	The scale consists of four subscales that measure stress related to (a) the sights and sounds of the unit (5 items), (b) the appearance and behaviours of the infant (19 items), (c) the impact on the parents' role and their relationship with their baby (10 items), and (d) the staff behaviours and communications (11 items). There is also a general stress-level question that summarizes the parents' overall feeling of stress related to having an infant in the NICU. The responses to the PSS: NICU were scored on a 5- point Likert scale from 0 to 5 where 0 means no experience at all with the situation or phenomenon, 1 (not at all stressful) to 5 (extremely stressful). Mean scores and standard deviation were obtained for each subscale and total scale separately for mothers and fathers and the overall stress scores was then calculated. Parental stress levels were classified according to the points on Likert scale as low (1-1.9), moderate (2-3.9) and high (4-5).	at 32, 34, and 37 weeks of gestation
Number of desaturation	Number of desaturation	every day betwenn 32 and 34 weeks of gestation
Number of vomiting	Number of vomiting	every day between 32 and 34 weeks of gestation
Exit age on return home	age of the infant when leaving the hospital	through study completion, an average of 41 week of gestation
Parental time in hours	time spend withe child	at 34 week of gestation and 37 week of gestation, calculated over 7 days
Number of meals and baths given by parents	Number of meals and baths given by parents	from 32 week of gestation to 37 week of gestation
Duration of transition from passive to active feeding in number of days	Duration of transition from passive to active feeding in number of days	from 32 week of gestation to 37 week of gestation
Average duration (minutes) of feeding/feeding	Average duration (minutes) of feeding/feeding	at 37 week of gestation
Number and duration of skin-to-skin sessions in minutes	Number and duration of skin-to-skin sessions in minutes	from inclusion to exit of service ( up to 45 week of gestation)
Duration of breastfeeding in number of days.	Duration of breastfeeding in number of days.	from 32 week of gestation to 37 week of gestation
Number of children with infant formula change	Number of children with infant formula change	between 32 week of gestation and 37 week of gestation
Evolution of the Z-weight score	The score shows the standard deviation above or below the mean on the growth chart. If you have looked at a growth chart of a patient or your own child, you will recall it contains curve shaped lines with various percentiles on it. The middle line is the 50th%Ile and they extend out to the 97%ile percentile and 3rd%Ile. So, a z score of 0 is the equivalent of the 50th%ile or average of what you are measuring (weight, height, weight for height or BMI) for that age. A z score of +1 means your plots fall at the 15th%ile or 85th%Ile and a z score of +2 falls roughly at the 3rd or 97%Ile. z scores run positively (+1. +2.+3) or negatively (-1, -2. -3) and so on.	32 week of gestation at the exit of the child.
Brunet-Lézine and Neurological Evaluation of Amiel Tison simplified by a psychomotor specialized in the development of premature babies to assess the psychomotor development of infants at	It may apply from the first month up to 5 years. It includes observations on posture, coordination, language, social-personal conduct. The Brunet-Lézine scale was developed by Odette Brunet and Irene Lézine. It provides a development quotient (Q.D.).	4 months of age corrected.
The Montreal Children's Hospital Feeding Scale [MCH-Feeding Scale]	scale for identification of feeding problems. The final scale consisted of 14 items covering the following feeding domains with some overlap: oral motor (items 8 and 11), oral sensory (items 7 and 8) and appetite (items 3 and 4). Other items covered maternal concerns about feeding (items 1, 2 and 12), mealtime behaviours (items 6 and 8), maternal strategies used (items 5, 9 and 10) and family reactions to their child's feeding (items 13 and 14). Each item is rated on a seven-point Likert scale with anchor points at either end. Seven items are scored from the negative to positive direction, and the other seven from the positive to negative direction. The primary feeder marks each item according to frequency or difficulty level of a particular behaviour or the level of parental concern. The total feeding problem score is obtained by adding the scores for each item after reversing the scores of seven items from negative to positive	4 months of age corrected
Number bradycardia	Number bradycardia	every day betwenn 32 and 34 weeks of gestation

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Le Laboratoire de Psychopathologie et Processus de Santé
• Investigators: Principal Investigator: Nelly THOMAS, Centre Hospitalier Intercommunal Créteil

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Premature; enteral nutrition; skin to skin; Parent-Child Relations; child at 32 of gestational age; push on syringe pump
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: PREMIAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No