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Effect of "Premature Infant Oral Motor Intervention" for early Transition to Oral Feeding in Preterm Infants: A Randomized Controlled Trial

Effect of Pre feeding Premature Infant Oral Motor Intervention for Transition from Gavage to Oral Feeding in Preterm Infants: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019853
Enrollment
32
Registered
2019-06-25
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: P073- Preterm [premature] newborn [other] Health Condition 2: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: â??Premature Infant Oral Motor Intervention" along with Non nutritive sucking: This group will receive â??Premature Infant Oral Motor Intervention" along with non nutritive sucking on e

Sponsors

Dr RML Hospital New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Preterm babies born between 28+0 â?? 32+6 weeks of gestation (by best gestational age estimate) and admitted to NICU who were hemodynamically stable, reached full gavage feeding and in transition from gavage to spoon feeds, receiving non-nutritive sucking and KMC as routine care.

Exclusion criteria

Exclusion criteria: Babies having respiratory distress, on continuous positive airway pressure /Ventilator, medical conditions like IVH grade 2 or beyond, NEC stage 2 or beyond, PVL, BPD and having chromosomal anomalies or congenital malformations

Design outcomes

Primary

MeasureTime frame
Time taken to transition from gavage feeds to full spoon feedsTimepoint: every 3rd day till full spoon feed is achieved

Secondary

MeasureTime frame
Breastfeeding rates at discharge and at 1 month after dischargeTimepoint: Every weekly till discharge and then every two weekly till 1 month after discharge;Episodes of bradycardia or desaturation (during or immediately after feeding) Timepoint: 2 to 3 times per day in the first week after initiation of intervention and subsequently, every 48 hours till discharge or till complete breast feeding was achieved;Late onset sepsis rates Timepoint: As and when the baby is symptomatic;Weight gain Timepoint: weekly till the attainment of full breastfeeding.

Countries

India

Contacts

Public ContactTapas Bandyopadhyay

PGIMER and Dr RML Hospital

drtapasbanerjee@gmail.com

Outcome results

None listed

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