Feeding Intolerance in Preterm Infants
Conditions
Keywords
Feeding intolerance Preterm infants
Brief summary
The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates. Preterm infants may have immature gastrointestinal function and reduced intestinal lactase activity, which may contribute to difficulty digesting lactose and symptoms of feeding intolerance. In this study, eligible preterm neonates will be randomly assigned to receive either lactase-treated milk feeds or placebo-treated milk feeds. Feeding tolerance will be assessed using clinical and nutritional parameters during the study period. The study will compare the two groups to determine whether lactase supplementation improves feeding tolerance and supports better progression of enteral feeding in preterm neonates. The hypothesis is that lactase-treated feeds will reduce feeding intolerance and facilitate achievement of adequate enteral feeding compared with placebo.
Detailed description
This is a randomized, controlled, parallel-group interventional study designed to evaluate the effect of lactase-treated feeds on feeding intolerance in preterm neonates. Preterm neonates are at increased risk of feeding intolerance because of gastrointestinal immaturity, delayed gastric emptying, immature intestinal motility, and incomplete development of digestive enzyme activity. Lactase activity may be relatively low in preterm infants, potentially resulting in incomplete lactose digestion and contributing to gastrointestinal symptoms associated with feeding intolerance. Eligible preterm neonates will be enrolled according to predefined inclusion and exclusion criteria. Participants will be randomly allocated into two groups. The intervention group will receive milk feeds treated with lactase enzyme, while the control group will receive milk feeds treated with placebo. The placebo will consist of distilled water administered in an equivalent manner to the lactase preparation. The study will evaluate feeding tolerance throughout the study period. Clinical parameters related to feeding tolerance will be recorded, including the occurrence and severity of feeding intolerance manifestations and the progression of enteral feeding. Nutritional and growth-related parameters will also be assessed according to the study protocol. The primary objective is to determine whether lactase-treated feeds improve feeding tolerance in preterm neonates compared with placebo-treated feeds. Secondary objectives include evaluating the effect of lactase supplementation on the progression of enteral feeding and selected nutritional and growth outcomes. The study is expected to provide evidence regarding whether exogenous lactase supplementation may be beneficial in preterm neonates experiencing feeding intolerance
Interventions
DRUGLactase enzyme
Lactase enzyme treated feeds
OTHERDistilled water
Distilled water administered as placebo to the control group during enteral feeding.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants, investigators, and care providers were masked to treatment allocation. The lactase preparation and placebo were administered in identical conditions to maintain blinding throughout the study.
Intervention model description
Participants will be randomly assigned to one of two parallel study groups. The intervention group will receive lactase-treated feeds, while the control group will receive placebo (distilled water) administered according to the study protocol. Participants will be followed prospectively to compare feeding tolerance and related clinical outcomes between the two groups.
Eligibility
Sex/Gender
ALL
Age
0 Days to 28 Days
Healthy volunteers
No
Inclusion criteria
* Gestational age \<34 weeks. * ≥2 symptoms suggestive of lactose intolerance: abdominal distension, abdominal pain, diarrhea, or diaper/nappy dermatitis. * Feeding intolerance defined by GRV \>3 mL/kg or the specified vomiting/stool/abdominal-distension.
Exclusion criteria
* Severe congenital malformations, including GI or cardiac defects. * NEC according to Bell's staging criteria. * Congenital diarrhea. * Hemodynamic instability requiring inotropes. * Amino-acid-based or lactose-free formula. * Guardian declines consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with diarrhea | From initiation of intervention to 2 weeks | Diarrhea will be assessed clinically according to stool frequency and consistency during the intervention period and recorded for each participant. |
| Mean change from baseline in gastric residual volume | From start of intervention till 2 weeks | Gastric residual volume measured in milliliters before feeding and serially during the intervention period. The outcome will be assessed by comparing the change in gastric residual volume from baseline between the lactase-treated feed group and the placebo group. |
| Number of participants with abdominal distension | From initiation of intervention to 2weeks | Abdominal distension assessed clinically by serial abdominal examination and abdominal circumference measurement during the intervention period. Participants with clinically evident abdominal distension will be recorded. |
| Number of participants with vomiting | From initiation of intervention to 2 weeks | Vomiting episodes will be assessed by clinical observation during the intervention period and recorded for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in head circumference | From initiation of intervention to 2 weeks | Head circumference measured in centimeters using a non-stretchable measuring tape placed around the largest occipital-frontal circumference. Measurements will be obtained at baseline and at the end of the intervention period. |
| Mean change from baseline in body length | From initiation of the study intervention till 2 weeks | Body length measured in centimeters using a standardized infant length board. Length will be assessed at baseline and at the end of the intervention period. |
| Mean change from baseline in body weight | From initiation of intervention to 2 weeks | Body weight measured in grams using a calibrated neonatal weighing scale. Weight will be measured serially during the study period and the change from baseline will be compared between the lactase-treated feed group and the placebo group. |
| Mean change from baseline in mid-upper arm circumference | From initiation of intervention to 2 weeks | Mid-upper arm circumference measured in centimeters using a non-stretchable measuring tape at the midpoint of the upper arm. Measurements will be obtained at baseline and at the end of the intervention period. |
Countries
Egypt
Contacts
STUDY_DIRECTOROla Galal
NICU of Ain shams university hospitals
Outcome results
None listed