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

Not Applicable

Completed

• Conditions: Preterm Infants
• Interventions: Behavioral: New Oral feeding process

• Registration Number: NCT04277806
• Lead Sponsor: Children's Hospital of Fudan University

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.

Detailed Description

In the neonatal intensive care unit, the attention of oral feeding of premature infants is far less than that of mechanical ventilation, antibiotics and other medical treatment, the use of parenteral nutrition, etc., and it is often not until the premature infants are enough mature and stable, or even before discharge that the caregivers pay attention to the problem of oral feeding. At this time, the corrected gestational age of premature infants is almost 36 weeks, but in fact the study shows that preterm infants have the ability of self feeding when they are about 32 weeks old. And oral feeding is very helpful to improve their nutritional status, reduce the use of parenteral nutrition and other forms of enteral nutrition, prevent complications and shorten the length of stay. Therefore, this study plans to use a new process to promote oral feeding and to verify whether it is feasible to earlier attainment of full oral feeding in premature infants.

Study Timeline

• Study First Submitted: 2020-02-13
• Study Start: 2020-02-15
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Primary Completion: 2020-08-15
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	New Oral feeding process	The preterm infants in this group would be fed according to the new process.

Primary Outcome Measures

Name	Time	Method
Age at full oral feeding	During the procedure	Days of life when the infant attain full oral feeding among two groups.

Secondary Outcome Measures

Name	Time	Method
Incidence of complications	During the procedure	Complications include NecrotizingEnterocolitis，any infections，Intraventricular hemorrhage，Bronchopulmonary dysplasia，etc. The variables of complications will be set to 1 as any symptoms mentioned above appeared during the hospitalization and none for 0. The incidence would be calculated in two groups.
The length of hospital stay	During the procedure	The length of hospital stay of participates in two groups.
Corrected gestational age at full oral feeding	During the procedure	Corrected gestational age when the infant attain full oral feeding among two groups.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China