Promoting Full Oral Feeding in Preterm Infants Less Than 30 Weeks Gestational Age

NCT04277806 | Completed DMC

• 1 other identifier: 2019-298
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.

Conditions

Preterm Infants

Outcome Measures

Primary Outcomes (1)

• Age at full oral feeding

  Days of life when the infant attain full oral feeding among two groups.

  During the procedure

Secondary Outcomes (3)

• The length of hospital stay

  During the procedure

• Incidence of complications

  During the procedure

• Corrected gestational age at full oral feeding

  During the procedure

Study Arms (2)

Standard group

NO INTERVENTION

No interventions would be conducted in this group and the preterm infants would be fed in the normal way.

Intervention group

EXPERIMENTAL

The preterm infants in this group would be fed according to the new process.

Behavioral: New Oral feeding process

Interventions

New Oral feeding process BEHAVIORAL

From the beginning of 32 weeks, try oral feeding once a day, suck pacifier for 10 minutes before feeding. When she/he can finish 50% of the amount of one meal in consecutive two days, and there is no adverse events happened, then we will try oral feeding twice a day. In the same way, in the oral feeding she/he can finish 50% of this meal in consecutive two days, there is no adverse events happened, then we will try three oral feedings three times a day. We wil continue the process until the infant can be fully oral fed by herself/himself.

Intervention group

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with gestational age less than 30 weeks
• The parents are positive to treat the infants

You may not qualify if:

• Fetal edema
• Very critical with OI more than 40
• Apgar score less than 5 at ten minutes after birth
• The parents refuse to treat the infants
• Severe IVH (more than grade IV )
• PVL
• Died before oral feeding starts

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The randomized allocation was concealed in double-enclosed, opaque, sealed and sequentially numbered envelops and opened when the infant was found to be eligible by the neonatal team in the NICU.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled study. Standard group: old protocol. Intervention group: New protocol.

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 20, 2020
• Study Start: February 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: September 30, 2020
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

CN (1)