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

Preterm Infants Clinical Trial

Official title:

Study on the New Feeding Protocol of Promoting Very Preterm Infants to Attain Full Oral Feeding Earlier

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04277806
• Other study ID #: 2019-298
• Status: Completed
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

Behavioral:
• New Oral feeding process
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.

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age at full oral feeding	Days of life when the infant attain full oral feeding among two groups.	During the procedure
Secondary	The length of hospital stay	The length of hospital stay of participates in two groups.	During the procedure
Secondary	Incidence of complications	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.	During the procedure
Secondary	Corrected gestational age at full oral feeding	Corrected gestational age when the infant attain full oral feeding among two groups.	During the procedure