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Completed

NCT Number: NCT04277806

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

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.

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Key information

Conditions

Age range

1 hour–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Age at full oral feeding

    Time frame: During the procedure

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

Secondary outcomes

  1. The length of hospital stay

    Time frame: During the procedure

    The length of hospital stay of participates in two groups.

  2. Incidence of complications

    Time frame: 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.

  3. Corrected gestational age at full oral feeding

    Time frame: During the procedure

    Corrected gestational age when the infant attain full oral feeding among two groups.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 20, 2020
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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