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Impact of Modified Feeding Protocol on Neonatal Outcomes

Impact of Modified Feeding Protocol on Neonatal Outcomes

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06246032
Enrollment
30
Registered
2024-02-07
Start date
2023-05-01
Completion date
2024-06-30
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Weight, Feeding Disorder Neonatal, Preterm

Keywords

Feeding protocol, Neonates, Preterm, Very low birthweight, NICU

Brief summary

The goal of this clinical trial is to compare modified feeding protocol and current feeding protocol on neonatal outcomes in preterm infants who born with weight less than 2kg. The main questions it aims to answer are: * Is Modified feeding protocol will decrease the duration of parenteral nutrition and length of hospital stay? * Is Modified feeding protocol feasible, efficient, and safe in preterm infants? Participants will undergo the modified feeding protocol since birth until discharge.

Detailed description

two group in this study Prospective group: intervention group will undergo the modified feeding protocol Retrospective group: intervention group will undergo the current feeding protocol Both group will have care as routine care to this kind of patients But the differ will be in feeding protocol as initiation rate, advancement rate, human milk fortification rate The outcomes of both group will be compeered to meet the study objectives

Interventions

OTHERModified feeding Protocol

Initiation of feeding (fixed): 10cc/kg Advancement based on birthweight (fixed): \<750g: 15cc/kg/d 750-999g: 20cc/kg/d 1000-1249g: 25cc/kg/d 1250-1499g: 25cc/kg/d 1500-1749g: 35cc/kg/d 1750-2000g: 35cc/kg/d Starting Human milk fortification when feed reach at 70cc/kg/d

Sponsors

Imam Abdulrahman Bin Faisal University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No

Inclusion criteria

* Birth weight (\<2000g) * Gestational Age (\<37 week)

Exclusion criteria

* Metabolic Disorders * Congenital Heart Diseases * Chronic Lung Disease * Congenital Anomalies (can related to feeding) * Moderate to severe GERD * Necrotizing enterocolitis stage 3 (surgical) * Gastrointestinal surgery

Design outcomes

Primary

MeasureTime frameDescription
Length of Stay (LOS)Up to 8 weeksNumber of days that participant stayed at hospital
Duration of Total Parenteral Nutrition (TPN)up to 2 weeksNumber of days that participant received Total Parenteral Nutrition (TPN)

Secondary

MeasureTime frameDescription
Incidence of Necrotizing EnterocolitisUp to 8 weeksStage 2, Stage 3
Incidence of Feeding intoleranceUp to 8 weeksabdominal grith more than 2 cm, gastric residual 50% of the last feed.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026