Oral Docosahexaenoic acid supplementation in Retinopathy of Prematurity in preterm

A Study on assessing the effect of enteral Docosahexaenoic acid in Retinopathy of prematurity :An open labelled randomised controlled trail - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/066292

Enrollment

Registered

2024-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

Intervention1: Enteral Docosahexaenoic supplementation: Enteral supplementation of Docosahexaenoic Acid at 7mg/kg for a period of4weeks Control Intervention1: Enteral Docosahexaenoic supplementation:

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with gestational age less than 34 weeks Birth weight less than 2000 grams Age less than 7 days Initiated on enteral feeds Informed and return concern of the parents/guardian

Exclusion criteria

Exclusion criteria: Neonates with major congenital malformations Neonates whose mother is on omega 3 supplements

Design outcomes

Primary

Measure	Time frame
Proportion of neonates with any stage of Retinopathy of prematurity according to International classification of Retinopathy of prematurity (ICROP) Criteria Timepoint: 4 weeks after administration of Docosahexaenoic acid	—

Secondary

Measure	Time frame
secondary outcome 1.Proportion of neonates with Stage 3 Retinopathy of prematurity 2.Proportion of Bronchopulmonary dysplasia 3.Proportion of Intraventricular hemorrhage more than or equal to grade 2 4.Proportion of Necrotising enterocolitis more than or equal to grade 2 5.Proportion of Extra Uterine Growth Retardation 6.Duration of hospital 7.MortalityTimepoint: 4weeks after administration of Docosahexaenoic acid	—

Measure

Time frame

secondary outcome 1.Proportion of neonates with Stage 3 Retinopathy of prematurity 2.Proportion of Bronchopulmonary dysplasia 3.Proportion of Intraventricular hemorrhage more than or equal to grade 2 4.Proportion of Necrotising enterocolitis more than or equal to grade 2 5.Proportion of Extra Uterine Growth Retardation 6.Duration of hospital 7.MortalityTimepoint: 4weeks after administration of Docosahexaenoic acid

—

Countries

India

Contacts

Public ContactCherukula sahithi

Indira Gandhi Institute of Child Health

brniranjan_hs@yahoo.com9505742023

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026