Shorten the Time Required to Correct the Arrival of Complete Oral Feeding in Premature Infants

Not Applicable

Completed

• Conditions: Premature Infants

• Registration Number: NCT05208437
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

Non-nutritive sucking combined with a step-by-step oral feeding regimen shortens the total oral feeding cycle in premature infants

Detailed Description

In order to improve the feeding of premature infants \<32 weeks of gestation, a complete oral feeding intervention program is provided for premature infants, which combined the evaluation of oral feeding readiness, the evaluation of oral feeding performance, non-nutritional sucking intervention and progressive feeding program. Premature infants will be assessed 12 times a day before feedings using the Feeding Preparation Scale.

Assess the premature infants by using the Feeding Preparation Scale. If the premature infant does not meet the oral feeding standard, let the premature infant use the non-nutritive sucking for 3 minutes before the nasal feeding; if the premature infant meets the oral feeding standard, use the non-nutritive sucking for 3 minutes, and refer to the feeding schedule for the premature infant. The whole intervention stops until the premature infant achieves the full oral feeding. Length of time required for complete oral feeding of premature infants is compared between the intervention group and the control group to evaluate the effect of the complete oral feeding intervention program on improving the feeding of premature infants \<32 weeks of gestation.

Study Timeline

• Study First Submitted: 2021-12-30
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-26
• Study Start: 2022-02-01
• Status Verified: 2023-02
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-31
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Gestational age <32w;
• Admit within 72 hours of birth;
• The guardian signs the informed consent;
• OI (oxygenation index >300)

Exclusion Criteria

• Newborns with severe congenital malformations or various chromosomal diseases, genetic metabolic diseases, severe neurological diseases;
• Newborns who die during the study;
• Newborns who drop out of the study;
• Newborns who have NEC during hospitalization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transition time from the initiation oral feeding to full oral feeding	During the procedure	Transition time was defined as the days needed from introduction of oral feeding to obtain autonomous oral feeding when the nasogastric tube was removed and all the daily milk volume was taken from the bottle.; time of complete oral feeding

Trial Locations

Locations (1)

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