Clinical trial NCT05117164: Enteral Feeding in Infants With Duct Dependant Lesions.
Official title: Effect of Standardised vs Local Preoperative Enteral Feeding Practice on the Incidence of NEC in Infants With Duct Dependent Lesions: a Randomised Control Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Duct Dependent Lesions
Necrotising Enterocolitis
Death
Growth
Keywords: congenital heart disease
nutrition
growth
newborn
Lead sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 384
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multicenter randomised controlled trial to assess whether standardised enteral feeding in newborns with duct dependenty congenital heart disease decreases the risk of necrotising enterocolitis (NEC). The investigators plan to include a total 384 infants. The study will be carried out in three level III hospitals in Poland. The primary end will be NEC and/or death. Secondary end points include weight gain, hospital length of stay, time required to reach full feeding.


Eligibility criteria: Inclusion criteria:

1. Duct dependent congenital heart disease
2. Term infants
3. Parental/legal guardian consent

Exclusion criteria:

1. Potential contradictions to early central feeding
2. Feeding intolerance
3. Hemodynamic instability
4. Death
5. \> 50% formula based enteral feeding
6. Birth weight less than 2500g

Primary outcomes:
measure: Proportion of final diagnosis of necrotizing enterocolitis (NEC).
timeFrame: up to two weeks life
measure: Proportion of death
timeFrame: up to two weeks life
Secondary outcomes:
measure: growth
timeFrame: Number of infants with a significant median change from baseline within 12 months
measure: Proportion of number of interrupted feedings
timeFrame: final value within 4 weeks
measure: Final median value of Vasoactive support
timeFrame: within 4 weeks
measure: Median change from baseline of protein intake
timeFrame: within 4 weeks
measure: Median change from baseline of caloric intake
timeFrame: within 4 weeks
measure: Proportion of final value of days required to reach full enteral feeding
timeFrame: within 4 weeks
measure: Proportion of final value of days on mechanical ventilation
timeFrame: within 4 weeks
measure: Proportion of final value of days required to regain birth weight
timeFrame: within 4 weeks
measure: Median change from baseline of breastfeeding of > 50%
timeFrame: within 12 months
measure: Proportion of culture proven late onset sepsis
timeFrame: 4 weeks
Other outcomes:
measure: Proportion of final value of age at transfer
timeFrame: 4 weeks
Locations:
city: Warsaw
country: Poland
facility: Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
city: Warsaw
country: Poland
facility: Princess Anna Mazowiecka Hospital
Study officials:
affiliation: Medical University of Warsaw
name: Renata Bokiniec, MD PhD
role: STUDY_CHAIR
affiliation: Medical University of Warsaw
name: Joanna Seliga-Siwecka, MD PhD
role: STUDY_DIRECTOR
affiliation: Medical University of Warsaw
name: Ariel Płotko
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Warsaw
name: Agata Wojcik-Sep
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seliga-Siwecka J, Plotko A, Wojcik-Sep A, Bokiniec R, Latka-Grot J, Zuk M, Furmanczyk K, Zielinski W, Chrzanowska M. Effect of standardized vs. local preoperative enteral feeding practice on the incidence of NEC in infants with duct dependent lesions: Protocol for a randomized control trial. Front Cardiovasc Med. 2022 Sep 8;9:893764. doi: 10.3389/fcvm.2022.893764. eCollection 2022.