Health Condition 1: P742- Disturbances of sodium balance ofnewborn
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Kasturba Medical College Manipal
Eligibility
Inclusion criteria
Inclusion criteria: Healthy term and late preterm neonates with gestational age greater than or equal to 34 weeks. Birth weight between 2000 and 4000 grams. Receiving exclusively or predominantly breast milk feeds. Neonates with excessive weight loss defined as weight loss greater than or equal to 10 percent of birth weight within the first week of life or greater than or equal to 5 percent within any 24 hour period.
Exclusion criteria
Exclusion criteria: Major congenital malformations. Formula feed or pasteurized donor human milk feed. Extra mural babies. Multiple gestation. Babies who require more than 1 extra feed within any 24 hour period after inclusion will be censored and removed from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of hypernatremia defined as serum sodium greater than or equal to 145 millimoles per liter among healthy late preterm and term breastfed neonates with excessive weight loss.Timepoint: Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage weight loss threshold associated with the presence of hypernatremia.Timepoint: Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier.;Strength and direction of correlation between percentage neonatal weight loss and serum sodium levels.Timepoint: Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier.;Strength and direction of correlation between maternal breast milk sodium levels and neonatal serum sodium levels.Timepoint: Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier.;Frequency and distribution of clinical features observed in neonates with excessive weight loss.Timepoint: Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier.;Association between serum sodium and serum creatinine levels and their relationship with clinical features in neonates with excessive weight loss.Timepoint: Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier.;Odds of hypernatremia and excessive weight loss in relation to maternal and neonatal factors expressed as odds ratios with 95 percent confidence intervals.Timepoint: Within the first postnatal week up to day 7 of life or discharge whichever occurs earlier. | — |
Countries
India
Contacts
Public ContactDr Riddhi Jain
Department Of Neonatology Kasturba Medical College Manipal
Outcome results
None listed