CompletedNot Applicable

Estimation of Nutritional Needs of Preterm Neonates Fed on Parenteral Nutrition and Effects on Body Weight Gain

Greece100 participantsStarted 2020-01-01

Plain-language summary

This randomized controlled trial included 100 preterm and small for gestational age neonates. The study aimed to determine the optimal approach for estimating nutritional needs in parenteral nutrition (PN) with the assistance of a specialized clinical decision support system (CDSS). More specifically, nutrient estimations based on the neonates' actual birth weight were compared to those calculated using the weight corresponding to the 10th percentile of the growth curve. The effect on growth outcomes over the PN course was investigated.

Who can participate

Age range1 Day – 1 Day

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * preterm neonates hospitalized in NICU and meeting the criteria for small for gestational age infants, i.e., neonates with birth weight under the 10th percentile, * preterm neonates receiving exclusive parenteral nutrition, and * parents' written consent for study participation. Exclusion Criteria: * term birth newborns or newborns not fullfilling the criteria of small for gestational age infants, * newborns with primary liver/bile duct disease, * newborns receiving enteral nutrition, and/or * neonates whose parents did not give a written consent to participate in the study

What they're measuring

Body weight change

Timeframe: From birth day (day 1) till the last day of parenteral nutrition support (study endpoint). Each neonate had different PN duration according to their clinical status (average 12 days).

Trial details

NCT IDNCT07236957

SponsorPanos Papandreou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Preterm Infant Development trials