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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
oral rehydration solution
intravenous infusion
Assistance Publique - Hôpitaux de Paris Hôpital Antoine Béclère
Clamart, France
Weight
Time frame: Day 0 to day 16 or day of recovering original birth day
Weight, length, head circumference and brachial circumference
Time frame: day 3, 15 of life, and at 37 GA.
Weight, Height/length, head circumference and brachial circumference
Time frame: 6 and 12 months
pathologic digestive diseases (enteropathy, NEC…)
Time frame: J0 to J16
metabolic tolerance during the first week of life: - hypoglycemia - fructose intolerance - bilirubin, electrolytes and creatinin level in blood
Time frame: during the first week of life
pain and discomfort score (EDIN) evaluated 3 times a day
Time frame: Day 0 to day 16
secondary IV infusion effects
Time frame: Day 0 to day 8
number of failure to pick and to perfuse a baby
Time frame: Day 0 to day 8
ORS culture
Time frame: in case of infection
Adverse Events
Time frame: Up to 12 months
Intestinal motility: - gastric residue - first meconium - first normal stool - number of stools during the first days of life
Time frame: the first two weeks of life
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.