Effect of prophylactic supplementation of sodium on prevention of late onset sodium deficiency in neonates less than 32 weeks - A double blinded placebo randomised control trial

Effect of prophylactic supplementation of sodium on prevention of late onset hyponatremia in neonates less than 32 weeks - A double blinded placebo randomised control trial - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/066608

Enrollment

Registered

2024-05-01

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

None listed

Interventions

Intervention1: supplementation of 3% saline solution: supplementation of 3% saline solution as oral or IV to preterms less than 32 weeks starting between 4 -7 days of life till 34 weeks or till develo

Eligibility

Inclusion criteria

Inclusion criteria: Preterm Neonates less than 32 weeks of gestation admitted within 7 days of life at NICU of ABVIMS and Dr. RML Hospital, New Delhi with Serum sodium 130-145 mEq/L by postnatal day 4

Exclusion criteria

Exclusion criteria: Presence of lethal congenital malformations or chromosomal abnormalities Presence of AKI (defined as an S. Creatinine rise more than or equal to0.3 mg/dl within 48 h or urine output less than 0.5 (ml/kg/h) for 6–12 h) Disease states (such as hydrops fetalis) that are characterized by edema- like hydrops fetalis, congestive heart failure within DOL 7 Refusal to consent

Design outcomes

Primary

Measure	Time frame
incidence of late onset hyponatremia among neonates less than 32 weeks given prophylactic sodium supplementation versus placeboTimepoint: incidence of late onset hyponatremia among neonates less than 32 weeks given prophylactic sodium supplementation versus placebo	—

Secondary

Measure	Time frame
1. To study the effect of prophylactic sodium supplementation in preterm neonates less than 32 weeks on their postnatal weight gain, length & head circumference weekly till discharge 2. To study the effect of sodium supplementation on the incidence of adverse effects like feed intolerance, hypernatremia, reopening of patent ductus arteriosus (PDA) during study period till discharge 3. To see the rate of supplementation failure, i.e development of hyponatremia (S, Na less than 135 mEq/L ) in the supplemented group till period of supplementation 4. To study the incidence of systemic hypertension at discharge in both the groups 5. To compare the incidence of other prematurity related morbidities like late onset sepsis, chronic lung disease, NEC more than stage II, in-hospital mortality & duration of hospital stay in both the groups. Timepoint: weekly till discharge & during the study period	—

Measure

Time frame

1. To study the effect of prophylactic sodium supplementation in preterm neonates less than 32 weeks on their postnatal weight gain, length & head circumference weekly till discharge 2. To study the effect of sodium supplementation on the incidence of adverse effects like feed intolerance, hypernatremia, reopening of patent ductus arteriosus (PDA) during study period till discharge 3. To see the rate of supplementation failure, i.e development of hyponatremia (S, Na less than 135 mEq/L ) in the supplemented group till period of supplementation 4. To study the incidence of systemic hypertension at discharge in both the groups 5. To compare the incidence of other prematurity related morbidities like late onset sepsis, chronic lung disease, NEC more than stage II, in-hospital mortality & duration of hospital stay in both the groups. Timepoint: weekly till discharge & during the study period

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Countries

India

Contacts

Public ContactDr Amrutha Visalakshi S

ABVIMS and RML hospital ,New Delhi

bhawnasd@yahoo.com9811520862

Outcome results