Low Birth Weight Infant, Enteral Nutrition
Conditions
Keywords
Preterm babies hydration, Oral rehydration solution, Continuous gastric drip, Fluid therapy, Premature babies comfort, Infant care, Technical challenge for the nurses/doctors in charge
Brief summary
This prospective randomised study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 32 weeks GA (gestational age) aims to determine whether administration of a hypo-osmolar oral hydration solution is as efficient as intravenous infusion.
Detailed description
In order to prevent dehydration of the premature infant during the first days of life, enteral nutrition with milk must be complemented by an additional fluid supply, commonly administered intravenously. We propose to perform a prospective randomised multi-centric study comparing administration of a hypo-osmolar oral hydration solution with the classical hydration via IV (intravenous) infusion in premature infants of more than 30 weeks GA (gestational age). We define success as a weight loss inferior to 15 % of birth weight and a weight at day 15 superior to birth weight. Failure was defined hence as a weight loss superior to 15% of birth weight or a weight at day 15 inferior to birth weight or a severe complication or death. Major violations of the protocol in the study group will be counted as failures. The other objectives were to determine whether oral hydration demonstrates practical advantages: less complications in initial management, more comfort for the baby and less technical challenges for the nurses/doctors in charge. Furthermore to evaluate the clinical tolerance of oral hydration from a nutritional point of view and to examine it's effects on intestinal function (defecation, gastric residues), signs of intestinal inflammation and GI flora.
Interventions
PROCEDUREOral rehydration therapy
oral rehydration solution
PROCEDUREclassical hydration via intravenous infusion
intravenous infusion
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 34 Weeks
Healthy volunteers
No
Inclusion criteria
* Premature babies between 32 to 34 + 6 weeks of gestation, with a birth weight greater than 1700g and less than 2200g under exclusion of SGA (small for gestational age) babies with a BW \< 10th percentile. * Infants must be included within the first 12 to 24 hours of life * Good tolerance to nasogastric milk feeding * Necessity of additional fluid supply * Any suspicion of gastro intestinal or metabolic disease * Maximal humidity in incubator * Parental consent form
Exclusion criteria
* suspicion of gastro-intestinal disease, * severe digestive risks, and metabolic diseases in the family history, * metabolic or hydro-electrolyte disorders * other severe diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight | Day 0 to day 16 or day of recovering original birth day |
Secondary
| Measure | Time frame |
|---|---|
| Weight, Height/length, head circumference and brachial circumference | 6 and 12 months |
| pathologic digestive diseases (enteropathy, NEC…) | J0 to J16 |
| metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood | during the first week of life |
| pain and discomfort score (EDIN) evaluated 3 times a day | Day 0 to day 16 |
| Weight, length, head circumference and brachial circumference | day 3, 15 of life, and at 37 GA. |
| number of failure to pick and to perfuse a baby | Day 0 to day 8 |
| ORS culture | in case of infection |
| Adverse Events | Up to 12 months |
| Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life | the first two weeks of life |
| secondary IV infusion effects | Day 0 to day 8 |
Countries
France
Outcome results
None listed