A scientific study to compare between NIFTY cup and Katori-spoon feeding on preterm neonates

An RCT to compare the effect of nifty cup vs. katori-spoon feeding on satisfaction, compliance, time taken of reach full oral feed, breast feed,length of hospital stay and adverse event among preterm neonates admitted in neonatal unit, PGIMER, Chandigarh , 2020-22

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/06/034252

Enrollment

106

Registered

2021-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: NIFTY CUP: It is a reusable cup made up of silicone. It has capacity of 40 ml. It has measurement marking over it and a groove from which the neonate can lap the milk. It will be used

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm neonate who are born before gestational age in neonatal units. 2. Is on orogastric/ nasogastric tube feeding and deemed fit to be started on oral feeds by clinician. 3. Preterm neonates whose Parents are able to Hindi, English and Punjabi language.

Exclusion criteria

Exclusion criteria: 1.Preterm Neonates with congenital malformations like cleft lip, cleft palate, omphalocele, gastroschisis 2. Preterm Neonates whose parents refused to consent for the intervention. 3. Preterm neonates with structural brain malformation, hypoxic ischemic encephalopathy, grade 3 or 4 IVH, neonatal seizures, necrotizing enterocolitis stage 2 or beyond, diagnosed case of severe gastro-esophageal reflux requiring anti-reflux medications, surgical GI malformation etc.

Design outcomes

Primary

Measure	Time frame
The primary outcome variable will be time taken to reach full oral feeds between two methods. Timepoint: 2 months	—

Secondary

Measure	Time frame
1. Time taken to reach full breastfeeds 2. Weekly weight gain among two groups 3. Length of hospital stay 4. Weight, length, and OFC at discharge 5. Duration of feeding session while baby is on full nifty cup/ Katori spoon feeding21 6. Adverse events (apnoea, choking, regurgitation, bradycardia, vomiting) 7. Compliance and satisfaction of mothers/caregivers (with a questionnaire) 8. Opinion of Nurses on feeding of preterm hospitalized neonate via NIFTY cupTimepoint: 2 months	—

Measure

Time frame

1. Time taken to reach full breastfeeds 2. Weekly weight gain among two groups 3. Length of hospital stay 4. Weight, length, and OFC at discharge 5. Duration of feeding session while baby is on full nifty cup/ Katori spoon feeding21 6. Adverse events (apnoea, choking, regurgitation, bradycardia, vomiting) 7. Compliance and satisfaction of mothers/caregivers (with a questionnaire) 8. Opinion of Nurses on feeding of preterm hospitalized neonate via NIFTY cupTimepoint: 2 months

—

Countries

India

Contacts

Public ContactMrs Geetanjli Kalyan

National Institute of Nursing Education PGIMER

geetss2@gmail.com7696028309

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026